task
stringlengths 12
101
| input
stringlengths 0
7.31k
| output
stringlengths 1
14.7k
| options
list | pageTitle
stringlengths 0
351
| outputColName
stringlengths 1
2.64k
| url
stringlengths 18
289
| wdcFile
stringlengths 68
75
|
|---|---|---|---|---|---|---|---|
03ba9f5b_port___Week_of_August_15__2012__Classification
|
[Product Type] Food [Product Description] River Ranch brand Iceberg/Romaine w/Color, 4 x 5 lb bag, UPC: n/a; Product is a salad item; bagged in clear polyethylene film (foodservice) and polypropylene/polyethylene (retail). Refrigerate and consume within Best By date. Product is processed and packaged by River Ranch Fresh Foods, LLC [Code Info] Best By code dates between 12MAY2012 - 29MAY2012; 12MAY2012 - 22MAY2012. The code date is located in the upper right hand corner of the bags. [Reason for Recall] River Ranch was notified that two separate samples of products pulled by the FDA which were produced by River Ranch, tested positive for Listeria monocytogenes. [Recalling Firm] River Ranch Fresh Foods LLC [Classification]
|
Class I
|
[
[
"C",
"l",
"a",
"s",
"s",
" ",
"I",
"I"
],
[
"C",
"l",
"a",
"s",
"s",
" ",
"I",
"I",
"I"
],
[
"C",
"l",
"a",
"s",
"s",
" ",
"I"
]
] |
Enforcement Report - Week of August 15, 2012
|
Classification
|
http://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=Expand+Index&w=08152012%E2%8C%A9=eng
|
0/1438042988061.16_20150728002308-00106-ip-10-236-191-2_271589034_0.json
|
03ba9f5b_port___Week_of_August_15__2012__Classification
|
[Product Type] Food [Product Description] River Ranch brand Shredded Icebreg (1/4"), (1/8"), 4 x 5 lb bag, UPC: n/a; Product is a salad item; bagged in clear polyethylene film (foodservice) and polypropylene/polyethylene (retail). Refrigerate and consume within Best By date. Product is processed and packaged by River Ranch Fresh Foods, LLC [Code Info] Best By code dates between 12MAY2012 - 29MAY2012; 12MAY2012 - 22MAY2012. The code date is located in the upper right hand corner of the bags. [Reason for Recall] River Ranch was notified that two separate samples of products pulled by the FDA which were produced by River Ranch, tested positive for Listeria monocytogenes. [Recalling Firm] River Ranch Fresh Foods LLC [Classification]
|
Class I
|
[
[
"C",
"l",
"a",
"s",
"s",
" ",
"I",
"I"
],
[
"C",
"l",
"a",
"s",
"s",
" ",
"I",
"I",
"I"
],
[
"C",
"l",
"a",
"s",
"s",
" ",
"I"
]
] |
Enforcement Report - Week of August 15, 2012
|
Classification
|
http://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=Expand+Index&w=08152012%E2%8C%A9=eng
|
0/1438042988061.16_20150728002308-00106-ip-10-236-191-2_271589034_0.json
|
03ba9f5b_port___Week_of_August_15__2012__Classification
|
[Product Type] Food [Product Description] River Ranch brand Iceberg & Romaine 50/50, 4 x 5lb bag, UPC: n/a; Product is a salad item; bagged in clear polyethylene film (foodservice) and polypropylene/polyethylene (retail). Refrigerate and consume within Best By date. Product is processed and packaged by River Ranch Fresh Foods, LLC [Code Info] Best By code dates between 12MAY2012 - 29MAY2012; 12MAY2012 - 22MAY2012. The code date is located in the upper right hand corner of the bags. [Reason for Recall] River Ranch was notified that two separate samples of products pulled by the FDA which were produced by River Ranch, tested positive for Listeria monocytogenes. [Recalling Firm] River Ranch Fresh Foods LLC [Classification]
|
Class I
|
[
[
"C",
"l",
"a",
"s",
"s",
" ",
"I",
"I"
],
[
"C",
"l",
"a",
"s",
"s",
" ",
"I",
"I",
"I"
],
[
"C",
"l",
"a",
"s",
"s",
" ",
"I"
]
] |
Enforcement Report - Week of August 15, 2012
|
Classification
|
http://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=Expand+Index&w=08152012%E2%8C%A9=eng
|
0/1438042988061.16_20150728002308-00106-ip-10-236-191-2_271589034_0.json
|
03ba9f5b_port___Week_of_August_15__2012__Classification
|
[Product Type] Food [Product Description] River Ranch brand Iceberg & Romaine, 4 x 5 lb bag, UPC: n/a; Product is a salad item; bagged in clear polyethylene film (foodservice) and polypropylene/polyethylene (retail). Refrigerate and consume within Best By date. Product is processed and packaged by River Ranch Fresh Foods, LLC [Code Info] Best By code dates between 12MAY2012 - 29MAY2012; 12MAY2012 - 22MAY2012. The code date is located in the upper right hand corner of the bags. [Reason for Recall] River Ranch was notified that two separate samples of products pulled by the FDA which were produced by River Ranch, tested positive for Listeria monocytogenes. [Recalling Firm] River Ranch Fresh Foods LLC [Classification]
|
Class I
|
[
[
"C",
"l",
"a",
"s",
"s",
" ",
"I",
"I"
],
[
"C",
"l",
"a",
"s",
"s",
" ",
"I",
"I",
"I"
],
[
"C",
"l",
"a",
"s",
"s",
" ",
"I"
]
] |
Enforcement Report - Week of August 15, 2012
|
Classification
|
http://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=Expand+Index&w=08152012%E2%8C%A9=eng
|
0/1438042988061.16_20150728002308-00106-ip-10-236-191-2_271589034_0.json
|
03ba9f5b_port___Week_of_August_15__2012__Classification
|
[Product Type] Food [Product Description] River Ranch brand Shredded Romaine, 6 x 2 lb bag, UPC: n/a; Product is a salad item; bagged in clear polyethylene film (foodservice) and polypropylene/polyethylene (retail). Refrigerate and consume within Best By date. Product is processed and packaged by River Ranch Fresh Foods, LLC [Code Info] Best By code dates between 12MAY2012 - 29MAY2012; 12MAY2012 - 22MAY2012. The code date is located in the upper right hand corner of the bags. [Reason for Recall] River Ranch was notified that two separate samples of products pulled by the FDA which were produced by River Ranch, tested positive for Listeria monocytogenes. [Recalling Firm] River Ranch Fresh Foods LLC [Classification]
|
Class I
|
[
[
"C",
"l",
"a",
"s",
"s",
" ",
"I",
"I"
],
[
"C",
"l",
"a",
"s",
"s",
" ",
"I",
"I",
"I"
],
[
"C",
"l",
"a",
"s",
"s",
" ",
"I"
]
] |
Enforcement Report - Week of August 15, 2012
|
Classification
|
http://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=Expand+Index&w=08152012%E2%8C%A9=eng
|
0/1438042988061.16_20150728002308-00106-ip-10-236-191-2_271589034_0.json
|
03ba9f5b_port___Week_of_August_15__2012__Classification
|
[Product Type] Food [Product Description] River Ranch brand Spring Mix, 3 lb bag, UPC: n/a; Product is a salad item; bagged in clear polyethylene film (foodservice) and polypropylene/polyethylene (retail). Refrigerate and consume within Best By date. Product is processed and packaged by River Ranch Fresh Foods, LLC [Code Info] Best By code dates between 12MAY2012 - 29MAY2012; 12MAY2012 - 22MAY2012. The code date is located in the upper right hand corner of the bags. [Reason for Recall] River Ranch was notified that two separate samples of products pulled by the FDA which were produced by River Ranch, tested positive for Listeria monocytogenes. [Recalling Firm] River Ranch Fresh Foods LLC [Classification]
|
Class II
|
[
[
"C",
"l",
"a",
"s",
"s",
" ",
"I",
"I"
],
[
"C",
"l",
"a",
"s",
"s",
" ",
"I",
"I",
"I"
],
[
"C",
"l",
"a",
"s",
"s",
" ",
"I"
]
] |
Enforcement Report - Week of August 15, 2012
|
Classification
|
http://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=Expand+Index&w=08152012%E2%8C%A9=eng
|
0/1438042988061.16_20150728002308-00106-ip-10-236-191-2_271589034_0.json
|
03ba9f5b_port___Week_of_August_15__2012__Classification
|
[Product Type] Food [Product Description] River Ranch brand Chopped Romaine w/ Liner, 6 x 2 lb bag, UPC: n/a; Product is a salad item; bagged in clear polyethylene film (foodservice) and polypropylene/polyethylene (retail). Refrigerate and consume within Best By date. Product is processed and packaged by River Ranch Fresh Foods, LLC [Code Info] Best By code dates between 12MAY2012 - 29MAY2012; 12MAY2012 - 22MAY2012. The code date is located in the upper right hand corner of the bags. [Reason for Recall] River Ranch was notified that two separate samples of products pulled by the FDA which were produced by River Ranch, tested positive for Listeria monocytogenes. [Recalling Firm] River Ranch Fresh Foods LLC [Classification]
|
Class I
|
[
[
"C",
"l",
"a",
"s",
"s",
" ",
"I",
"I"
],
[
"C",
"l",
"a",
"s",
"s",
" ",
"I",
"I",
"I"
],
[
"C",
"l",
"a",
"s",
"s",
" ",
"I"
]
] |
Enforcement Report - Week of August 15, 2012
|
Classification
|
http://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=Expand+Index&w=08152012%E2%8C%A9=eng
|
0/1438042988061.16_20150728002308-00106-ip-10-236-191-2_271589034_0.json
|
03ba9f5b_port___Week_of_August_15__2012__Classification
|
[Product Type] Food [Product Description] Cross Valley brand Shred Grn Cabbage w/Color, 4 x 5 lb bag, UPC: n/a; Product is a salad item; bagged in clear polyethylene film (foodservice) and polypropylene/polyethylene (retail). Refrigerate and consume within Best By date. Product is processed and packaged by River Ranch Fresh Foods, LLC [Code Info] Best By code dates between 12MAY2012 - 29MAY2012; 12MAY2012 - 22MAY2012. The code date is located in the upper right hand corner of the bags. [Reason for Recall] River Ranch was notified that two separate samples of products pulled by the FDA which were produced by River Ranch, tested positive for Listeria monocytogenes. [Recalling Firm] River Ranch Fresh Foods LLC [Classification]
|
Class II
|
[
[
"C",
"l",
"a",
"s",
"s",
" ",
"I",
"I"
],
[
"C",
"l",
"a",
"s",
"s",
" ",
"I",
"I",
"I"
],
[
"C",
"l",
"a",
"s",
"s",
" ",
"I"
]
] |
Enforcement Report - Week of August 15, 2012
|
Classification
|
http://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=Expand+Index&w=08152012%E2%8C%A9=eng
|
0/1438042988061.16_20150728002308-00106-ip-10-236-191-2_271589034_0.json
|
03ba9f5b_port___Week_of_August_15__2012__Classification
|
[Product Type] Food [Product Description] Cross Valley brand Chopped Iceberg, 4 x 5 lb bag, UPC: n/a; Product is a salad item; bagged in clear polyethylene film (foodservice) and polypropylene/polyethylene (retail). Refrigerate and consume within Best By date. Product is processed and packaged by River Ranch Fresh Foods, LLC [Code Info] Best By code dates between 12MAY2012 - 29MAY2012; 12MAY2012 - 22MAY2012. The code date is located in the upper right hand corner of the bags. [Reason for Recall] River Ranch was notified that two separate samples of products pulled by the FDA which were produced by River Ranch, tested positive for Listeria monocytogenes. [Recalling Firm] River Ranch Fresh Foods LLC [Classification]
|
Class I
|
[
[
"C",
"l",
"a",
"s",
"s",
" ",
"I",
"I"
],
[
"C",
"l",
"a",
"s",
"s",
" ",
"I",
"I",
"I"
],
[
"C",
"l",
"a",
"s",
"s",
" ",
"I"
]
] |
Enforcement Report - Week of August 15, 2012
|
Classification
|
http://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=Expand+Index&w=08152012%E2%8C%A9=eng
|
0/1438042988061.16_20150728002308-00106-ip-10-236-191-2_271589034_0.json
|
03ba9f5b_port___Week_of_August_15__2012__Classification
|
[Product Type] Food [Product Description] Cross Valley brand Iceberg Salad Mix, 4 x 5lb bag, UPC: n/a; Product is a salad item; bagged in clear polyethylene film (foodservice) and polypropylene/polyethylene (retail). Refrigerate and consume within Best By date. Product is processed and packaged by River Ranch Fresh Foods, LLC [Code Info] Best By code dates between 12MAY2012 - 29MAY2012; 12MAY2012 - 22MAY2012. The code date is located in the upper right hand corner of the bags. [Reason for Recall] River Ranch was notified that two separate samples of products pulled by the FDA which were produced by River Ranch, tested positive for Listeria monocytogenes. [Recalling Firm] River Ranch Fresh Foods LLC [Classification]
|
Class I
|
[
[
"C",
"l",
"a",
"s",
"s",
" ",
"I",
"I"
],
[
"C",
"l",
"a",
"s",
"s",
" ",
"I",
"I",
"I"
],
[
"C",
"l",
"a",
"s",
"s",
" ",
"I"
]
] |
Enforcement Report - Week of August 15, 2012
|
Classification
|
http://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=Expand+Index&w=08152012%E2%8C%A9=eng
|
0/1438042988061.16_20150728002308-00106-ip-10-236-191-2_271589034_0.json
|
03ba9f5b_port___Week_of_August_15__2012__Classification
|
[Product Type] Food [Product Description] Cross Valley brand Garden with Romaine, 4 x 5 lb bag, UPC: n/a; Product is a salad item; bagged in clear polyethylene film (foodservice) and polypropylene/polyethylene (retail). Refrigerate and consume within Best By date. Product is processed and packaged by River Ranch Fresh Foods, LLC [Code Info] Best By code dates between 12MAY2012 - 29MAY2012; 12MAY2012 - 22MAY2012. The code date is located in the upper right hand corner of the bags. [Reason for Recall] River Ranch was notified that two separate samples of products pulled by the FDA which were produced by River Ranch, tested positive for Listeria monocytogenes. [Recalling Firm] River Ranch Fresh Foods LLC [Classification]
|
Class I
|
[
[
"C",
"l",
"a",
"s",
"s",
" ",
"I",
"I"
],
[
"C",
"l",
"a",
"s",
"s",
" ",
"I",
"I",
"I"
],
[
"C",
"l",
"a",
"s",
"s",
" ",
"I"
]
] |
Enforcement Report - Week of August 15, 2012
|
Classification
|
http://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=Expand+Index&w=08152012%E2%8C%A9=eng
|
0/1438042988061.16_20150728002308-00106-ip-10-236-191-2_271589034_0.json
|
03ba9f5b_port___Week_of_August_15__2012__Classification
|
[Product Type] Food [Product Description] Cross Valley brand Chopped Iceberg w/Color, 4 x 5 lb bag, UPC: n/a; Product is a salad item; bagged in clear polyethylene film (foodservice) and polypropylene/polyethylene (retail). Refrigerate and consume within Best By date. Product is processed and packaged by River Ranch Fresh Foods, LLC [Code Info] Best By code dates between 12MAY2012 - 29MAY2012; 12MAY2012 - 22MAY2012. The code date is located in the upper right hand corner of the bags. [Reason for Recall] River Ranch was notified that two separate samples of products pulled by the FDA which were produced by River Ranch, tested positive for Listeria monocytogenes. [Recalling Firm] River Ranch Fresh Foods LLC [Classification]
|
Class I
|
[
[
"C",
"l",
"a",
"s",
"s",
" ",
"I",
"I"
],
[
"C",
"l",
"a",
"s",
"s",
" ",
"I",
"I",
"I"
],
[
"C",
"l",
"a",
"s",
"s",
" ",
"I"
]
] |
Enforcement Report - Week of August 15, 2012
|
Classification
|
http://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=Expand+Index&w=08152012%E2%8C%A9=eng
|
0/1438042988061.16_20150728002308-00106-ip-10-236-191-2_271589034_0.json
|
03ba9f5b_port___Week_of_August_15__2012__Classification
|
[Product Type] Food [Product Description] Cross Valley brand Iceberg / Romaine w/Color, 4 x 5 lb bag, UPC: n/a; Product is a salad item; bagged in clear polyethylene film (foodservice) and polypropylene/polyethylene (retail). Refrigerate and consume within Best By date. Product is processed and packaged by River Ranch Fresh Foods, LLC [Code Info] Best By code dates between 12MAY2012 - 29MAY2012; 12MAY2012 - 22MAY2012. The code date is located in the upper right hand corner of the bags. [Reason for Recall] River Ranch was notified that two separate samples of products pulled by the FDA which were produced by River Ranch, tested positive for Listeria monocytogenes. [Recalling Firm] River Ranch Fresh Foods LLC [Classification]
|
Class I
|
[
[
"C",
"l",
"a",
"s",
"s",
" ",
"I",
"I"
],
[
"C",
"l",
"a",
"s",
"s",
" ",
"I",
"I",
"I"
],
[
"C",
"l",
"a",
"s",
"s",
" ",
"I"
]
] |
Enforcement Report - Week of August 15, 2012
|
Classification
|
http://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=Expand+Index&w=08152012%E2%8C%A9=eng
|
0/1438042988061.16_20150728002308-00106-ip-10-236-191-2_271589034_0.json
|
03ba9f5b_port___Week_of_August_15__2012__Classification
|
[Product Type] Food [Product Description] Cross Valley brand Shredded Icebreg (1/4"), (1/8") 4 x 5 lb bag, UPC: n/a; Product is a salad item; bagged in clear polyethylene film (foodservice) and polypropylene/polyethylene (retail). Refrigerate and consume within Best By date. Product is processed and packaged by River Ranch Fresh Foods, LLC [Code Info] Best By code dates between 12MAY2012 - 29MAY2012; 12MAY2012 - 22MAY2012. The code date is located in the upper right hand corner of the bags. [Reason for Recall] River Ranch was notified that two separate samples of products pulled by the FDA which were produced by River Ranch, tested positive for Listeria monocytogenes. [Recalling Firm] River Ranch Fresh Foods LLC [Classification]
|
Class I
|
[
[
"C",
"l",
"a",
"s",
"s",
" ",
"I",
"I"
],
[
"C",
"l",
"a",
"s",
"s",
" ",
"I",
"I",
"I"
],
[
"C",
"l",
"a",
"s",
"s",
" ",
"I"
]
] |
Enforcement Report - Week of August 15, 2012
|
Classification
|
http://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=Expand+Index&w=08152012%E2%8C%A9=eng
|
0/1438042988061.16_20150728002308-00106-ip-10-236-191-2_271589034_0.json
|
03ba9f5b_port___Week_of_August_15__2012__Classification
|
[Product Type] Food [Product Description] Fresh n Easy brand Shred Grn Cabbage w/Color, 4 x 5 lb bag, UPC: n/a; Product is a salad item; bagged in clear polyethylene film (foodservice) and polypropylene/polyethylene (retail). Refrigerate and consume within Best By date. Product is processed and packaged by River Ranch Fresh Foods, LLC [Code Info] Best By code dates between 12MAY2012 - 29MAY2012; 12MAY2012 - 22MAY2012. The code date is located in the upper right hand corner of the bags. [Reason for Recall] River Ranch was notified that two separate samples of products pulled by the FDA which were produced by River Ranch, tested positive for Listeria monocytogenes. [Recalling Firm] River Ranch Fresh Foods LLC [Classification]
|
Class II
|
[
[
"C",
"l",
"a",
"s",
"s",
" ",
"I",
"I"
],
[
"C",
"l",
"a",
"s",
"s",
" ",
"I",
"I",
"I"
],
[
"C",
"l",
"a",
"s",
"s",
" ",
"I"
]
] |
Enforcement Report - Week of August 15, 2012
|
Classification
|
http://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=Expand+Index&w=08152012%E2%8C%A9=eng
|
0/1438042988061.16_20150728002308-00106-ip-10-236-191-2_271589034_0.json
|
03ba9f5b_port___Week_of_August_15__2012__Classification
|
[Product Type] Food [Product Description] Fresh n Easy brand Chopped Iceberg, 4 x 5 lb bag, UPC: n/a; Product is a salad item; bagged in clear polyethylene film (foodservice) and polypropylene/polyethylene (retail). Refrigerate and consume within Best By date. Product is processed and packaged by River Ranch Fresh Foods, LLC [Code Info] Best By code dates between 12MAY2012 - 29MAY2012; 12MAY2012 - 22MAY2012. The code date is located in the upper right hand corner of the bags. [Reason for Recall] River Ranch was notified that two separate samples of products pulled by the FDA which were produced by River Ranch, tested positive for Listeria monocytogenes. [Recalling Firm] River Ranch Fresh Foods LLC [Classification]
|
Class I
|
[
[
"C",
"l",
"a",
"s",
"s",
" ",
"I",
"I"
],
[
"C",
"l",
"a",
"s",
"s",
" ",
"I",
"I",
"I"
],
[
"C",
"l",
"a",
"s",
"s",
" ",
"I"
]
] |
Enforcement Report - Week of August 15, 2012
|
Classification
|
http://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=Expand+Index&w=08152012%E2%8C%A9=eng
|
0/1438042988061.16_20150728002308-00106-ip-10-236-191-2_271589034_0.json
|
03ba9f5b_port___Week_of_August_15__2012__Classification
|
[Product Type] Food [Product Description] Fresh n Easy brand Garden with Romaine, 4 x 5 lb bag, UPC: n/a; Product is a salad item; bagged in clear polyethylene film (foodservice) and polypropylene/polyethylene (retail). Refrigerate and consume within Best By date. Product is processed and packaged by River Ranch Fresh Foods, LLC [Code Info] Best By code dates between 12MAY2012 - 29MAY2012; 12MAY2012 - 22MAY2012. The code date is located in the upper right hand corner of the bags. [Reason for Recall] River Ranch was notified that two separate samples of products pulled by the FDA which were produced by River Ranch, tested positive for Listeria monocytogenes. [Recalling Firm] River Ranch Fresh Foods LLC [Classification]
|
Class I
|
[
[
"C",
"l",
"a",
"s",
"s",
" ",
"I",
"I"
],
[
"C",
"l",
"a",
"s",
"s",
" ",
"I",
"I",
"I"
],
[
"C",
"l",
"a",
"s",
"s",
" ",
"I"
]
] |
Enforcement Report - Week of August 15, 2012
|
Classification
|
http://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=Expand+Index&w=08152012%E2%8C%A9=eng
|
0/1438042988061.16_20150728002308-00106-ip-10-236-191-2_271589034_0.json
|
03ba9f5b_port___Week_of_August_15__2012__Classification
|
[Product Type] Food [Product Description] Fresh n Easy brand Chopped Iceberg w/ Color, 4 x 5 lb bag, UPC: n/a; Product is a salad item; bagged in clear polyethylene film (foodservice) and polypropylene/polyethylene (retail). Refrigerate and consume within Best By date. Product is processed and packaged by River Ranch Fresh Foods, LLC [Code Info] Best By code dates between 12MAY2012 - 29MAY2012; 12MAY2012 - 22MAY2012. The code date is located in the upper right hand corner of the bags. [Reason for Recall] River Ranch was notified that two separate samples of products pulled by the FDA which were produced by River Ranch, tested positive for Listeria monocytogenes. [Recalling Firm] River Ranch Fresh Foods LLC [Classification]
|
Class I
|
[
[
"C",
"l",
"a",
"s",
"s",
" ",
"I",
"I"
],
[
"C",
"l",
"a",
"s",
"s",
" ",
"I",
"I",
"I"
],
[
"C",
"l",
"a",
"s",
"s",
" ",
"I"
]
] |
Enforcement Report - Week of August 15, 2012
|
Classification
|
http://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=Expand+Index&w=08152012%E2%8C%A9=eng
|
0/1438042988061.16_20150728002308-00106-ip-10-236-191-2_271589034_0.json
|
03ba9f5b_port___Week_of_August_15__2012__Classification
|
[Product Type] Food [Product Description] Fresh n Easy brand Shredded Icebreg (1/4"), (1/8"), 4 x 5 lb bag, UPC: n/a; Product is a salad item; bagged in clear polyethylene film (foodservice) and polypropylene/polyethylene (retail). Refrigerate and consume within Best By date. Product is processed and packaged by River Ranch Fresh Foods, LLC [Code Info] Best By code dates between 12MAY2012 - 29MAY2012; 12MAY2012 - 22MAY2012. The code date is located in the upper right hand corner of the bags. [Reason for Recall] River Ranch was notified that two separate samples of products pulled by the FDA which were produced by River Ranch, tested positive for Listeria monocytogenes. [Recalling Firm] River Ranch Fresh Foods LLC [Classification]
|
Class I
|
[
[
"C",
"l",
"a",
"s",
"s",
" ",
"I",
"I"
],
[
"C",
"l",
"a",
"s",
"s",
" ",
"I",
"I",
"I"
],
[
"C",
"l",
"a",
"s",
"s",
" ",
"I"
]
] |
Enforcement Report - Week of August 15, 2012
|
Classification
|
http://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=Expand+Index&w=08152012%E2%8C%A9=eng
|
0/1438042988061.16_20150728002308-00106-ip-10-236-191-2_271589034_0.json
|
03ba9f5b_port___Week_of_August_15__2012__Classification
|
[Product Type] Food [Product Description] Promark brand Chopped Iceberg w/ Color, 4 x 5 lb bag, UPC: n/a; Product is a salad item; bagged in clear polyethylene film (foodservice) and polypropylene/polyethylene (retail). Refrigerate and consume within Best By date. Product is processed and packaged by River Ranch Fresh Foods, LLC [Code Info] Best By code dates between 12MAY2012 - 29MAY2012; 12MAY2012 - 22MAY2012. The code date is located in the upper right hand corner of the bags. [Reason for Recall] River Ranch was notified that two separate samples of products pulled by the FDA which were produced by River Ranch, tested positive for Listeria monocytogenes. [Recalling Firm] River Ranch Fresh Foods LLC [Classification]
|
Class I
|
[
[
"C",
"l",
"a",
"s",
"s",
" ",
"I",
"I"
],
[
"C",
"l",
"a",
"s",
"s",
" ",
"I",
"I",
"I"
],
[
"C",
"l",
"a",
"s",
"s",
" ",
"I"
]
] |
Enforcement Report - Week of August 15, 2012
|
Classification
|
http://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=Expand+Index&w=08152012%E2%8C%A9=eng
|
0/1438042988061.16_20150728002308-00106-ip-10-236-191-2_271589034_0.json
|
03ba9f5b_port___Week_of_August_15__2012__Classification
|
[Product Type] Food [Product Description] Promark brand Shredded Icebreg (1/8"), 4 x 5 lb bag, UPC: n/a; Product is a salad item; bagged in clear polyethylene film (foodservice) and polypropylene/polyethylene (retail). Refrigerate and consume within Best By date. Product is processed and packaged by River Ranch Fresh Foods, LLC [Code Info] Best By code dates between 12MAY2012 - 29MAY2012; 12MAY2012 - 22MAY2012. The code date is located in the upper right hand corner of the bags. [Reason for Recall] River Ranch was notified that two separate samples of products pulled by the FDA which were produced by River Ranch, tested positive for Listeria monocytogenes. [Recalling Firm] River Ranch Fresh Foods LLC [Classification]
|
Class I
|
[
[
"C",
"l",
"a",
"s",
"s",
" ",
"I",
"I"
],
[
"C",
"l",
"a",
"s",
"s",
" ",
"I",
"I",
"I"
],
[
"C",
"l",
"a",
"s",
"s",
" ",
"I"
]
] |
Enforcement Report - Week of August 15, 2012
|
Classification
|
http://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=Expand+Index&w=08152012%E2%8C%A9=eng
|
0/1438042988061.16_20150728002308-00106-ip-10-236-191-2_271589034_0.json
|
03ba9f5b_port___Week_of_August_15__2012__Classification
|
[Product Type] Food [Product Description] Sysco brand Shred Grn Cabbage w/ Color, 4 x 5 lb bag, UPC: n/a; Product is a salad item; bagged in clear polyethylene film (foodservice) and polypropylene/polyethylene (retail). Refrigerate and consume within Best By date. Product is processed and packaged by River Ranch Fresh Foods, LLC [Code Info] Best By code dates between 12MAY2012 - 29MAY2012; 12MAY2012 - 22MAY2012. The code date is located in the upper right hand corner of the bags. [Reason for Recall] River Ranch was notified that two separate samples of products pulled by the FDA which were produced by River Ranch, tested positive for Listeria monocytogenes. [Recalling Firm] River Ranch Fresh Foods LLC [Classification]
|
Class II
|
[
[
"C",
"l",
"a",
"s",
"s",
" ",
"I",
"I"
],
[
"C",
"l",
"a",
"s",
"s",
" ",
"I",
"I",
"I"
],
[
"C",
"l",
"a",
"s",
"s",
" ",
"I"
]
] |
Enforcement Report - Week of August 15, 2012
|
Classification
|
http://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=Expand+Index&w=08152012%E2%8C%A9=eng
|
0/1438042988061.16_20150728002308-00106-ip-10-236-191-2_271589034_0.json
|
03ba9f5b_port___Week_of_August_15__2012__Classification
|
[Product Type] Food [Product Description] Sysco brand Chopped Iceberg, 4 x 5 lb bag, UPC: n/a; Product is a salad item; bagged in clear polyethylene film (foodservice) and polypropylene/polyethylene (retail). Refrigerate and consume within Best By date. Product is processed and packaged by River Ranch Fresh Foods, LLC [Code Info] Best By code dates between 12MAY2012 - 29MAY2012; 12MAY2012 - 22MAY2012. The code date is located in the upper right hand corner of the bags. [Reason for Recall] River Ranch was notified that two separate samples of products pulled by the FDA which were produced by River Ranch, tested positive for Listeria monocytogenes. [Recalling Firm] River Ranch Fresh Foods LLC [Classification]
|
Class I
|
[
[
"C",
"l",
"a",
"s",
"s",
" ",
"I",
"I"
],
[
"C",
"l",
"a",
"s",
"s",
" ",
"I",
"I",
"I"
],
[
"C",
"l",
"a",
"s",
"s",
" ",
"I"
]
] |
Enforcement Report - Week of August 15, 2012
|
Classification
|
http://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=Expand+Index&w=08152012%E2%8C%A9=eng
|
0/1438042988061.16_20150728002308-00106-ip-10-236-191-2_271589034_0.json
|
03ba9f5b_port___Week_of_August_15__2012__Classification
|
[Product Type] Food [Product Description] Sysco brand Iceberg Salad Mix, 4 x 5 lb bag, UPC: n/a; Product is a salad item; bagged in clear polyethylene film (foodservice) and polypropylene/polyethylene (retail). Refrigerate and consume within Best By date. Product is processed and packaged by River Ranch Fresh Foods, LLC [Code Info] Best By code dates between 12MAY2012 - 29MAY2012; 12MAY2012 - 22MAY2012. The code date is located in the upper right hand corner of the bags. [Reason for Recall] River Ranch was notified that two separate samples of products pulled by the FDA which were produced by River Ranch, tested positive for Listeria monocytogenes. [Recalling Firm] River Ranch Fresh Foods LLC [Classification]
|
Class I
|
[
[
"C",
"l",
"a",
"s",
"s",
" ",
"I",
"I"
],
[
"C",
"l",
"a",
"s",
"s",
" ",
"I",
"I",
"I"
],
[
"C",
"l",
"a",
"s",
"s",
" ",
"I"
]
] |
Enforcement Report - Week of August 15, 2012
|
Classification
|
http://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=Expand+Index&w=08152012%E2%8C%A9=eng
|
0/1438042988061.16_20150728002308-00106-ip-10-236-191-2_271589034_0.json
|
03ba9f5b_port___Week_of_August_15__2012__Classification
|
[Product Type] Food [Product Description] Sysco brand Garden with Romaine, 4 x 5 lb bag, UPC: n/a; Product is a salad item; bagged in clear polyethylene film (foodservice) and polypropylene/polyethylene (retail). Refrigerate and consume within Best By date. Product is processed and packaged by River Ranch Fresh Foods, LLC [Code Info] Best By code dates between 12MAY2012 - 29MAY2012; 12MAY2012 - 22MAY2012. The code date is located in the upper right hand corner of the bags. [Reason for Recall] River Ranch was notified that two separate samples of products pulled by the FDA which were produced by River Ranch, tested positive for Listeria monocytogenes. [Recalling Firm] River Ranch Fresh Foods LLC [Classification]
|
Class I
|
[
[
"C",
"l",
"a",
"s",
"s",
" ",
"I",
"I"
],
[
"C",
"l",
"a",
"s",
"s",
" ",
"I",
"I",
"I"
],
[
"C",
"l",
"a",
"s",
"s",
" ",
"I"
]
] |
Enforcement Report - Week of August 15, 2012
|
Classification
|
http://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=Expand+Index&w=08152012%E2%8C%A9=eng
|
0/1438042988061.16_20150728002308-00106-ip-10-236-191-2_271589034_0.json
|
03ba9f5b_port___Week_of_August_15__2012__Classification
|
[Product Type] Food [Product Description] Sysco brand Chopped Iceberg w/ Color, 4 x 5 lb bag, UPC: n/a; Product is a salad item; bagged in clear polyethylene film (foodservice) and polypropylene/polyethylene (retail). Refrigerate and consume within Best By date. Product is processed and packaged by River Ranch Fresh Foods, LLC [Code Info] Best By code dates between 12MAY2012 - 29MAY2012; 12MAY2012 - 22MAY2012. The code date is located in the upper right hand corner of the bags. [Reason for Recall] River Ranch was notified that two separate samples of products pulled by the FDA which were produced by River Ranch, tested positive for Listeria monocytogenes. [Recalling Firm] River Ranch Fresh Foods LLC [Classification]
|
Class I
|
[
[
"C",
"l",
"a",
"s",
"s",
" ",
"I",
"I"
],
[
"C",
"l",
"a",
"s",
"s",
" ",
"I",
"I",
"I"
],
[
"C",
"l",
"a",
"s",
"s",
" ",
"I"
]
] |
Enforcement Report - Week of August 15, 2012
|
Classification
|
http://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=Expand+Index&w=08152012%E2%8C%A9=eng
|
0/1438042988061.16_20150728002308-00106-ip-10-236-191-2_271589034_0.json
|
03ba9f5b_port___Week_of_August_15__2012__Classification
|
[Product Type] Food [Product Description] Sysco brand Shredded Iceberg (1/4"), (1/8") 4 x 5 lb bag, UPCs: n/a; Product is a salad item; bagged in clear polyethylene film (foodservice) and polypropylene/polyethylene (retail). Refrigerate and consume within Best By date. Product is processed and packaged by River Ranch Fresh Foods, LLC [Code Info] Best By code dates between 12MAY2012 - 29MAY2012; 12MAY2012 - 22MAY2012. The code date is located in the upper right hand corner of the bags. [Reason for Recall] River Ranch was notified that two separate samples of products pulled by the FDA which were produced by River Ranch, tested positive for Listeria monocytogenes. [Recalling Firm] River Ranch Fresh Foods LLC [Classification]
|
Class I
|
[
[
"C",
"l",
"a",
"s",
"s",
" ",
"I",
"I"
],
[
"C",
"l",
"a",
"s",
"s",
" ",
"I",
"I",
"I"
],
[
"C",
"l",
"a",
"s",
"s",
" ",
"I"
]
] |
Enforcement Report - Week of August 15, 2012
|
Classification
|
http://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=Expand+Index&w=08152012%E2%8C%A9=eng
|
0/1438042988061.16_20150728002308-00106-ip-10-236-191-2_271589034_0.json
|
03ba9f5b_port___Week_of_August_15__2012__Classification
|
[Product Type] Food [Product Description] Sysco brand Chopped Romaine, 6 x 2 lb bag, UPC: n/a; Product is a salad item; bagged in clear polyethylene film (foodservice) and polypropylene/polyethylene (retail). Refrigerate and consume within Best By date. Product is processed and packaged by River Ranch Fresh Foods, LLC [Code Info] Best By code dates between 12MAY2012 - 29MAY2012; 12MAY2012 - 22MAY2012. The code date is located in the upper right hand corner of the bags. [Reason for Recall] River Ranch was notified that two separate samples of products pulled by the FDA which were produced by River Ranch, tested positive for Listeria monocytogenes. [Recalling Firm] River Ranch Fresh Foods LLC [Classification]
|
Class I
|
[
[
"C",
"l",
"a",
"s",
"s",
" ",
"I",
"I"
],
[
"C",
"l",
"a",
"s",
"s",
" ",
"I",
"I",
"I"
],
[
"C",
"l",
"a",
"s",
"s",
" ",
"I"
]
] |
Enforcement Report - Week of August 15, 2012
|
Classification
|
http://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=Expand+Index&w=08152012%E2%8C%A9=eng
|
0/1438042988061.16_20150728002308-00106-ip-10-236-191-2_271589034_0.json
|
03ba9f5b_port___Week_of_August_15__2012__Classification
|
[Product Type] Food [Product Description] Sysco brand Spring Mix, 3 lb bag, UPC: n/a; Product is a salad item; bagged in clear polyethylene film (foodservice) and polypropylene/polyethylene (retail). Refrigerate and consume within Best By date. Product is processed and packaged by River Ranch Fresh Foods, LLC [Code Info] Best By code dates between 12MAY2012 - 29MAY2012; 12MAY2012 - 22MAY2012. The code date is located in the upper right hand corner of the bags. [Reason for Recall] River Ranch was notified that two separate samples of products pulled by the FDA which were produced by River Ranch, tested positive for Listeria monocytogenes. [Recalling Firm] River Ranch Fresh Foods LLC [Classification]
|
Class II
|
[
[
"C",
"l",
"a",
"s",
"s",
" ",
"I",
"I"
],
[
"C",
"l",
"a",
"s",
"s",
" ",
"I",
"I",
"I"
],
[
"C",
"l",
"a",
"s",
"s",
" ",
"I"
]
] |
Enforcement Report - Week of August 15, 2012
|
Classification
|
http://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=Expand+Index&w=08152012%E2%8C%A9=eng
|
0/1438042988061.16_20150728002308-00106-ip-10-236-191-2_271589034_0.json
|
03ba9f5b_port___Week_of_August_15__2012__Classification
|
[Product Type] Biologics [Product Description] Plasma Cryoprecipitated Reduced [Code Info] W043210088572 [Reason for Recall] Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed. [Recalling Firm] Blood Assurance Inc [Classification]
|
Class II
|
[
[
"C",
"l",
"a",
"s",
"s",
" ",
"I",
"I"
],
[
"C",
"l",
"a",
"s",
"s",
" ",
"I",
"I",
"I"
],
[
"C",
"l",
"a",
"s",
"s",
" ",
"I"
]
] |
Enforcement Report - Week of August 15, 2012
|
Classification
|
http://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=Expand+Index&w=08152012%E2%8C%A9=eng
|
0/1438042988061.16_20150728002308-00106-ip-10-236-191-2_271589034_0.json
|
03ba9f5b_port___Week_of_August_15__2012__Classification
|
[Product Type] Biologics [Product Description] Red Blood Cells (Apheresis) Leukocytes Reduced [Code Info] W043211094961-A; W043211094961-B; W043211044082-A; W043211025338-A; W043211044082-B; W043211025338-B [Reason for Recall] Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed. [Recalling Firm] Blood Assurance Inc [Classification]
|
Class II
|
[
[
"C",
"l",
"a",
"s",
"s",
" ",
"I",
"I"
],
[
"C",
"l",
"a",
"s",
"s",
" ",
"I",
"I",
"I"
],
[
"C",
"l",
"a",
"s",
"s",
" ",
"I"
]
] |
Enforcement Report - Week of August 15, 2012
|
Classification
|
http://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=Expand+Index&w=08152012%E2%8C%A9=eng
|
0/1438042988061.16_20150728002308-00106-ip-10-236-191-2_271589034_0.json
|
03ba9f5b_port___Week_of_August_15__2012__Classification
|
[Product Type] Biologics [Product Description] Cryoprecipitated AHF, Pooled [Code Info] W043210088572 [Reason for Recall] Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed. [Recalling Firm] Blood Assurance Inc [Classification]
|
Class II
|
[
[
"C",
"l",
"a",
"s",
"s",
" ",
"I",
"I"
],
[
"C",
"l",
"a",
"s",
"s",
" ",
"I",
"I",
"I"
],
[
"C",
"l",
"a",
"s",
"s",
" ",
"I"
]
] |
Enforcement Report - Week of August 15, 2012
|
Classification
|
http://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=Expand+Index&w=08152012%E2%8C%A9=eng
|
0/1438042988061.16_20150728002308-00106-ip-10-236-191-2_271589034_0.json
|
03ba9f5b_port___Week_of_August_15__2012__Classification
|
[Product Type] Biologics [Product Description] Red Blood Cells Leukocytes Reduced [Code Info] V89413; V26698; W043210088572; W043210075817 [Reason for Recall] Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed. [Recalling Firm] Blood Assurance Inc [Classification]
|
Class II
|
[
[
"C",
"l",
"a",
"s",
"s",
" ",
"I",
"I"
],
[
"C",
"l",
"a",
"s",
"s",
" ",
"I",
"I",
"I"
],
[
"C",
"l",
"a",
"s",
"s",
" ",
"I"
]
] |
Enforcement Report - Week of August 15, 2012
|
Classification
|
http://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=Expand+Index&w=08152012%E2%8C%A9=eng
|
0/1438042988061.16_20150728002308-00106-ip-10-236-191-2_271589034_0.json
|
03ba9f5b_port___Week_of_August_15__2012__Classification
|
[Product Type] Biologics [Product Description] Plasma Frozen within 24 hours (FP24) [Code Info] W043210075817 [Reason for Recall] Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed. [Recalling Firm] Blood Assurance Inc [Classification]
|
Class II
|
[
[
"C",
"l",
"a",
"s",
"s",
" ",
"I",
"I"
],
[
"C",
"l",
"a",
"s",
"s",
" ",
"I",
"I",
"I"
],
[
"C",
"l",
"a",
"s",
"s",
" ",
"I"
]
] |
Enforcement Report - Week of August 15, 2012
|
Classification
|
http://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=Expand+Index&w=08152012%E2%8C%A9=eng
|
0/1438042988061.16_20150728002308-00106-ip-10-236-191-2_271589034_0.json
|
03ba9f5b_port___Week_of_August_15__2012__Classification
|
[Product Type] Biologics [Product Description] Blood and Blood Products for Reprocessing [Code Info] V89413 [Reason for Recall] Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed. [Recalling Firm] Blood Assurance Inc [Classification]
|
Class II
|
[
[
"C",
"l",
"a",
"s",
"s",
" ",
"I",
"I"
],
[
"C",
"l",
"a",
"s",
"s",
" ",
"I",
"I",
"I"
],
[
"C",
"l",
"a",
"s",
"s",
" ",
"I"
]
] |
Enforcement Report - Week of August 15, 2012
|
Classification
|
http://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=Expand+Index&w=08152012%E2%8C%A9=eng
|
0/1438042988061.16_20150728002308-00106-ip-10-236-191-2_271589034_0.json
|
03ba9f5b_port___Week_of_August_15__2012__Classification
|
[Product Type] Biologics [Product Description] Fresh Frozen Plasma [Code Info] V26698 [Reason for Recall] Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed. [Recalling Firm] Blood Assurance Inc [Classification]
|
Class II
|
[
[
"C",
"l",
"a",
"s",
"s",
" ",
"I",
"I"
],
[
"C",
"l",
"a",
"s",
"s",
" ",
"I",
"I",
"I"
],
[
"C",
"l",
"a",
"s",
"s",
" ",
"I"
]
] |
Enforcement Report - Week of August 15, 2012
|
Classification
|
http://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=Expand+Index&w=08152012%E2%8C%A9=eng
|
0/1438042988061.16_20150728002308-00106-ip-10-236-191-2_271589034_0.json
|
03ba9f5b_port___Week_of_August_15__2012__Classification
|
[Product Type] Biologics [Product Description] Red Blood Cells Leukocytes Reduced [Code Info] W043211081138 [Reason for Recall] Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed. [Recalling Firm] Blood Assurance Inc [Classification]
|
Class II
|
[
[
"C",
"l",
"a",
"s",
"s",
" ",
"I",
"I"
],
[
"C",
"l",
"a",
"s",
"s",
" ",
"I",
"I",
"I"
],
[
"C",
"l",
"a",
"s",
"s",
" ",
"I"
]
] |
Enforcement Report - Week of August 15, 2012
|
Classification
|
http://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=Expand+Index&w=08152012%E2%8C%A9=eng
|
0/1438042988061.16_20150728002308-00106-ip-10-236-191-2_271589034_0.json
|
03ba9f5b_port___Week_of_August_15__2012__Classification
|
[Product Type] Biologics [Product Description] Blood and Blood Products for Reprocessing [Code Info] W043211081138 [Reason for Recall] Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed. [Recalling Firm] Blood Assurance Inc [Classification]
|
Class III
|
[
[
"C",
"l",
"a",
"s",
"s",
" ",
"I",
"I"
],
[
"C",
"l",
"a",
"s",
"s",
" ",
"I",
"I",
"I"
],
[
"C",
"l",
"a",
"s",
"s",
" ",
"I"
]
] |
Enforcement Report - Week of August 15, 2012
|
Classification
|
http://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=Expand+Index&w=08152012%E2%8C%A9=eng
|
0/1438042988061.16_20150728002308-00106-ip-10-236-191-2_271589034_0.json
|
03ba9f5b_port___Week_of_August_15__2012__Classification
|
[Product Type] Biologics [Product Description] Platelets Leukocytes Reduced [Code Info] W115911013637 [Reason for Recall] Blood products, collected from a donor who traveled to a malarial endemic area, were distributed. [Recalling Firm] Central California Blood Center [Classification]
|
Class II
|
[
[
"C",
"l",
"a",
"s",
"s",
" ",
"I",
"I"
],
[
"C",
"l",
"a",
"s",
"s",
" ",
"I",
"I",
"I"
],
[
"C",
"l",
"a",
"s",
"s",
" ",
"I"
]
] |
Enforcement Report - Week of August 15, 2012
|
Classification
|
http://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=Expand+Index&w=08152012%E2%8C%A9=eng
|
0/1438042988061.16_20150728002308-00106-ip-10-236-191-2_271589034_0.json
|
03ba9f5b_port___Week_of_August_15__2012__Classification
|
[Product Type] Biologics [Product Description] Red Blood Cells Leukocytes Reduced [Code Info] W115911274353; W115911045584 [Reason for Recall] Blood products, collected from a donor who traveled to a malarial endemic area, were distributed. [Recalling Firm] Central California Blood Center [Classification]
|
Class II
|
[
[
"C",
"l",
"a",
"s",
"s",
" ",
"I",
"I"
],
[
"C",
"l",
"a",
"s",
"s",
" ",
"I",
"I",
"I"
],
[
"C",
"l",
"a",
"s",
"s",
" ",
"I"
]
] |
Enforcement Report - Week of August 15, 2012
|
Classification
|
http://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=Expand+Index&w=08152012%E2%8C%A9=eng
|
0/1438042988061.16_20150728002308-00106-ip-10-236-191-2_271589034_0.json
|
03ba9f5b_port___Week_of_August_15__2012__Classification
|
[Product Type] Biologics [Product Description] Source Plasma [Code Info] 2160057721; 2160058109; 2160060202; 2160073434; 2160078442; [Reason for Recall] Blood Products, collected from a donor, whose suitability to donate was not adequately determined, were distributed. [Recalling Firm] Plasmacare Inc [Classification]
|
Class III
|
[
[
"C",
"l",
"a",
"s",
"s",
" ",
"I",
"I"
],
[
"C",
"l",
"a",
"s",
"s",
" ",
"I",
"I",
"I"
],
[
"C",
"l",
"a",
"s",
"s",
" ",
"I"
]
] |
Enforcement Report - Week of August 15, 2012
|
Classification
|
http://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=Expand+Index&w=08152012%E2%8C%A9=eng
|
0/1438042988061.16_20150728002308-00106-ip-10-236-191-2_271589034_0.json
|
03ba9f5b_port___Week_of_August_15__2012__Classification
|
[Product Type] Biologics [Product Description] Plasma Frozen within 24 hours (FP24) [Code Info] W037911146400 [Reason for Recall] Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed. [Recalling Firm] LifeServe Blood Center [Classification]
|
Class II
|
[
[
"C",
"l",
"a",
"s",
"s",
" ",
"I",
"I"
],
[
"C",
"l",
"a",
"s",
"s",
" ",
"I",
"I",
"I"
],
[
"C",
"l",
"a",
"s",
"s",
" ",
"I"
]
] |
Enforcement Report - Week of August 15, 2012
|
Classification
|
http://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=Expand+Index&w=08152012%E2%8C%A9=eng
|
0/1438042988061.16_20150728002308-00106-ip-10-236-191-2_271589034_0.json
|
03ba9f5b_port___Week_of_August_15__2012__Classification
|
[Product Type] Biologics [Product Description] Blood and Blood Products for Reprocessing [Code Info] W037911171995 [Reason for Recall] Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed. [Recalling Firm] LifeServe Blood Center [Classification]
|
Class II
|
[
[
"C",
"l",
"a",
"s",
"s",
" ",
"I",
"I"
],
[
"C",
"l",
"a",
"s",
"s",
" ",
"I",
"I",
"I"
],
[
"C",
"l",
"a",
"s",
"s",
" ",
"I"
]
] |
Enforcement Report - Week of August 15, 2012
|
Classification
|
http://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=Expand+Index&w=08152012%E2%8C%A9=eng
|
0/1438042988061.16_20150728002308-00106-ip-10-236-191-2_271589034_0.json
|
03ba9f5b_port___Week_of_August_15__2012__Classification
|
[Product Type] Biologics [Product Description] Red Blood Cells Leukocytes Reduced [Code Info] 017FR95345 [Reason for Recall] Blood product, incorrectly labeled for Jk(a) red cell antigen, was distributed. [Recalling Firm] American National Red Cross (The) - North Central Region [Classification]
|
Class II
|
[
[
"C",
"l",
"a",
"s",
"s",
" ",
"I",
"I"
],
[
"C",
"l",
"a",
"s",
"s",
" ",
"I",
"I",
"I"
],
[
"C",
"l",
"a",
"s",
"s",
" ",
"I"
]
] |
Enforcement Report - Week of August 15, 2012
|
Classification
|
http://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=Expand+Index&w=08152012%E2%8C%A9=eng
|
0/1438042988061.16_20150728002308-00106-ip-10-236-191-2_271589034_0.json
|
03ba9f5b_port___Week_of_August_15__2012__Classification
|
[Product Type] Devices [Product Description] SoftLab with SA INST versions: 3.1.6.12, 4.0.1.26-4.0.1.32, 4.0.2.21-4.0.2.51, and 4.0.3.5-4.0.3.13. Product UsageSoftLab is a laboratory information system to be used in a medical research or clinical laboratory by knowledgeable, trained, and experienced personnel. SoftLab enables the user to handle data-processing and laboratory activities, for the purpose of storing, managing, querying, and reporting laboratory data. [Code Info] SA INST versions: 3.1.6.12, 4.0.1.26-4.0.1.32, 4.0.2.21-4.0.2.51, and 4.0.3.5-4.0.3.13. [Reason for Recall] On 10/17/2011 SCC Soft Computer, Clearwater, FL initiated a correction on SoftLab with SA INST versions: 3.1.6.12, 4.0.1.26-4.0.1.32, 4.0.2.21-4.0.2.51, and 4.0.3.5-4.0.3.13. A client reported an issue which caused two different sets of results from the Sysmex series of Hematology instruments to display under the same order on the instrument menu. [Recalling Firm] SCC Soft Computer [Classification]
|
Class II
|
[
[
"C",
"l",
"a",
"s",
"s",
" ",
"I",
"I"
],
[
"C",
"l",
"a",
"s",
"s",
" ",
"I",
"I",
"I"
],
[
"C",
"l",
"a",
"s",
"s",
" ",
"I"
]
] |
Enforcement Report - Week of August 15, 2012
|
Classification
|
http://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=Expand+Index&w=08152012%E2%8C%A9=eng
|
0/1438042988061.16_20150728002308-00106-ip-10-236-191-2_271589034_0.json
|
03ba9f5b_port___Week_of_August_15__2012__Classification
|
[Product Type] Biologics [Product Description] Red Blood Cells [Code Info] W071911006426; W071912000837 [Reason for Recall] Blood products, collected from a donor who traveled to a malarial endemic area, were distributed. [Recalling Firm] So Ca Permamente Med Group Blood Donor Cntr [Classification]
|
Class II
|
[
[
"C",
"l",
"a",
"s",
"s",
" ",
"I",
"I"
],
[
"C",
"l",
"a",
"s",
"s",
" ",
"I",
"I",
"I"
],
[
"C",
"l",
"a",
"s",
"s",
" ",
"I"
]
] |
Enforcement Report - Week of August 15, 2012
|
Classification
|
http://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=Expand+Index&w=08152012%E2%8C%A9=eng
|
0/1438042988061.16_20150728002308-00106-ip-10-236-191-2_271589034_0.json
|
03ba9f5b_port___Week_of_August_15__2012__Classification
|
[Product Type] Biologics [Product Description] Blood and Blood Products for Reprocessing [Code Info] W038111302401 [Reason for Recall] Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed. [Recalling Firm] Florida's Blood Centers, Inc. [Classification]
|
Class II
|
[
[
"C",
"l",
"a",
"s",
"s",
" ",
"I",
"I"
],
[
"C",
"l",
"a",
"s",
"s",
" ",
"I",
"I",
"I"
],
[
"C",
"l",
"a",
"s",
"s",
" ",
"I"
]
] |
Enforcement Report - Week of August 15, 2012
|
Classification
|
http://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=Expand+Index&w=08152012%E2%8C%A9=eng
|
0/1438042988061.16_20150728002308-00106-ip-10-236-191-2_271589034_0.json
|
03ba9f5b_port___Week_of_August_15__2012__Classification
|
[Product Type] Food [Product Description] "***Tres Monjitas***Tropical Splash***Guanabana***15 oz***" [Code Info] Lot # 0464 [Reason for Recall] Undeclared sub-ingredients considered allergens: hydrogenated coconut oil, sodium caseinate and soy lecithin. [Recalling Firm] Altura Food, Inc. [Classification]
|
Class I
|
[
[
"C",
"l",
"a",
"s",
"s",
" ",
"I",
"I"
],
[
"C",
"l",
"a",
"s",
"s",
" ",
"I",
"I",
"I"
],
[
"C",
"l",
"a",
"s",
"s",
" ",
"I"
]
] |
Enforcement Report - Week of August 15, 2012
|
Classification
|
http://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=Expand+Index&w=08152012%E2%8C%A9=eng
|
0/1438042988061.16_20150728002308-00106-ip-10-236-191-2_271589034_0.json
|
03ba9f5b_port___Week_of_August_15__2012__Classification
|
[Product Type] Food [Product Description] "***Tres Monjitas***Tropical Splash***Acerola***15 oz***" [Code Info] Lot 0465 [Reason for Recall] Undeclared sub-ingredients considered allergens: hydrogenated coconut oil, sodium caseinate and soy lecithin. [Recalling Firm] Altura Food, Inc. [Classification]
|
Class I
|
[
[
"C",
"l",
"a",
"s",
"s",
" ",
"I",
"I"
],
[
"C",
"l",
"a",
"s",
"s",
" ",
"I",
"I",
"I"
],
[
"C",
"l",
"a",
"s",
"s",
" ",
"I"
]
] |
Enforcement Report - Week of August 15, 2012
|
Classification
|
http://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=Expand+Index&w=08152012%E2%8C%A9=eng
|
0/1438042988061.16_20150728002308-00106-ip-10-236-191-2_271589034_0.json
|
03ba9f5b_port___Week_of_August_15__2012__Classification
|
[Product Type] Drugs [Product Description] Copaxone (glatiramer acetate injection), 20mg/mL, 1 mL , Rx only, Marketed by: Teva Neuroscience - NDC 68546-317-30 [Code Info] Lot number X05011, Exp 08/13 [Reason for Recall] Presence of Foreign Substance: Recall is being initiated due to the presence of a foreign particle identified from a customer complaint. [Recalling Firm] Teva Pharmaceuticals USA, Inc. [Classification]
|
Class II
|
[
[
"C",
"l",
"a",
"s",
"s",
" ",
"I",
"I"
],
[
"C",
"l",
"a",
"s",
"s",
" ",
"I",
"I",
"I"
],
[
"C",
"l",
"a",
"s",
"s",
" ",
"I"
]
] |
Enforcement Report - Week of August 15, 2012
|
Classification
|
http://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=Expand+Index&w=08152012%E2%8C%A9=eng
|
0/1438042988061.16_20150728002308-00106-ip-10-236-191-2_271589034_0.json
|
03ba9f5b_port___Week_of_August_15__2012__Classification
|
[Product Type] Biologics [Product Description] Source Plasma [Code Info] 2160080280; 2160063587; 2160083178 [Reason for Recall] Blood products, collected from a donor, whose suitability to donate was not adequately determined, was distributed. [Recalling Firm] Plasmacare Inc [Classification]
|
Class III
|
[
[
"C",
"l",
"a",
"s",
"s",
" ",
"I",
"I"
],
[
"C",
"l",
"a",
"s",
"s",
" ",
"I",
"I",
"I"
],
[
"C",
"l",
"a",
"s",
"s",
" ",
"I"
]
] |
Enforcement Report - Week of August 15, 2012
|
Classification
|
http://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=Expand+Index&w=08152012%E2%8C%A9=eng
|
0/1438042988061.16_20150728002308-00106-ip-10-236-191-2_271589034_0.json
|
03ba9f5b_port___Week_of_August_15__2012__Classification
|
[Product Type] Biologics [Product Description] Source Plasma [Code Info] 2160077796 [Reason for Recall] Blood Product, collected from a donor, whose suitability to donate was not adequately determined, was distributed. [Recalling Firm] Plasmacare Inc [Classification]
|
Class III
|
[
[
"C",
"l",
"a",
"s",
"s",
" ",
"I",
"I"
],
[
"C",
"l",
"a",
"s",
"s",
" ",
"I",
"I",
"I"
],
[
"C",
"l",
"a",
"s",
"s",
" ",
"I"
]
] |
Enforcement Report - Week of August 15, 2012
|
Classification
|
http://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=Expand+Index&w=08152012%E2%8C%A9=eng
|
0/1438042988061.16_20150728002308-00106-ip-10-236-191-2_271589034_0.json
|
03ba9f5b_port___Week_of_August_15__2012__Classification
|
[Product Type] Biologics [Product Description] Source Plasma [Code Info] 2160080329; 2160082127 [Reason for Recall] Blood Products, collected from a donor, whose suitability to donate was not adequately determined, were distributed. [Recalling Firm] Plasmacare Inc [Classification]
|
Class III
|
[
[
"C",
"l",
"a",
"s",
"s",
" ",
"I",
"I"
],
[
"C",
"l",
"a",
"s",
"s",
" ",
"I",
"I",
"I"
],
[
"C",
"l",
"a",
"s",
"s",
" ",
"I"
]
] |
Enforcement Report - Week of August 15, 2012
|
Classification
|
http://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=Expand+Index&w=08152012%E2%8C%A9=eng
|
0/1438042988061.16_20150728002308-00106-ip-10-236-191-2_271589034_0.json
|
03ba9f5b_port___Week_of_August_15__2012__Classification
|
[Product Type] Biologics [Product Description] Source Plasma [Code Info] 2160076394 [Reason for Recall] Blood Product, collected from a donor, whose suitability to donate was not adequately determined, was distributed. [Recalling Firm] Plasmacare Inc [Classification]
|
Class III
|
[
[
"C",
"l",
"a",
"s",
"s",
" ",
"I",
"I"
],
[
"C",
"l",
"a",
"s",
"s",
" ",
"I",
"I",
"I"
],
[
"C",
"l",
"a",
"s",
"s",
" ",
"I"
]
] |
Enforcement Report - Week of August 15, 2012
|
Classification
|
http://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=Expand+Index&w=08152012%E2%8C%A9=eng
|
0/1438042988061.16_20150728002308-00106-ip-10-236-191-2_271589034_0.json
|
03ba9f5b_port___Week_of_August_15__2012__Classification
|
[Product Type] Biologics [Product Description] Source Plasma [Code Info] 12KWIA3540; 12KWIA3311; 12KWIA2924 [Reason for Recall] Blood products, collected from a donor who was previously deferred, were distributed. [Recalling Firm] Interstate Blood Bank, Inc. WI [Classification]
|
Class III
|
[
[
"C",
"l",
"a",
"s",
"s",
" ",
"I",
"I"
],
[
"C",
"l",
"a",
"s",
"s",
" ",
"I",
"I",
"I"
],
[
"C",
"l",
"a",
"s",
"s",
" ",
"I"
]
] |
Enforcement Report - Week of August 15, 2012
|
Classification
|
http://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=Expand+Index&w=08152012%E2%8C%A9=eng
|
0/1438042988061.16_20150728002308-00106-ip-10-236-191-2_271589034_0.json
|
03ba9f5b_port___Week_of_August_15__2012__Classification
|
[Product Type] Biologics [Product Description] Source Plasma [Code Info] NQ078882 [Reason for Recall] Blood product, collected from a donor in which donor suitability was not adequately determined, was distributed. [Recalling Firm] Plasma Biological Services, Inc [Classification]
|
Class II
|
[
[
"C",
"l",
"a",
"s",
"s",
" ",
"I",
"I"
],
[
"C",
"l",
"a",
"s",
"s",
" ",
"I",
"I",
"I"
],
[
"C",
"l",
"a",
"s",
"s",
" ",
"I"
]
] |
Enforcement Report - Week of August 15, 2012
|
Classification
|
http://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=Expand+Index&w=08152012%E2%8C%A9=eng
|
0/1438042988061.16_20150728002308-00106-ip-10-236-191-2_271589034_0.json
|
03ba9f5b_port___Week_of_August_15__2012__Classification
|
[Product Type] Biologics [Product Description] Red Blood Cells Leukocytes Reduced [Code Info] W229812501160 [Reason for Recall] Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed. [Recalling Firm] Blood Center of Northcentral Wisconsin, Inc. [Classification]
|
Class II
|
[
[
"C",
"l",
"a",
"s",
"s",
" ",
"I",
"I"
],
[
"C",
"l",
"a",
"s",
"s",
" ",
"I",
"I",
"I"
],
[
"C",
"l",
"a",
"s",
"s",
" ",
"I"
]
] |
Enforcement Report - Week of August 15, 2012
|
Classification
|
http://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=Expand+Index&w=08152012%E2%8C%A9=eng
|
0/1438042988061.16_20150728002308-00106-ip-10-236-191-2_271589034_0.json
|
03ba9f5b_port___Week_of_August_15__2012__Classification
|
[Product Type] Biologics [Product Description] Fresh Frozen Plasma [Code Info] W229812501160 [Reason for Recall] Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed. [Recalling Firm] Blood Center of Northcentral Wisconsin, Inc. [Classification]
|
Class II
|
[
[
"C",
"l",
"a",
"s",
"s",
" ",
"I",
"I"
],
[
"C",
"l",
"a",
"s",
"s",
" ",
"I",
"I",
"I"
],
[
"C",
"l",
"a",
"s",
"s",
" ",
"I"
]
] |
Enforcement Report - Week of August 15, 2012
|
Classification
|
http://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=Expand+Index&w=08152012%E2%8C%A9=eng
|
0/1438042988061.16_20150728002308-00106-ip-10-236-191-2_271589034_0.json
|
03ba9f5b_port___Week_of_August_15__2012__Classification
|
[Product Type] Biologics [Product Description] Red Blood Cells [Code Info] W038512380006 [Reason for Recall] Blood product, collected from a donor who traveled to a malarial endemic area, was distributed. [Recalling Firm] Walter L. Shepeard Community Blood Center, Inc. [Classification]
|
Class II
|
[
[
"C",
"l",
"a",
"s",
"s",
" ",
"I",
"I"
],
[
"C",
"l",
"a",
"s",
"s",
" ",
"I",
"I",
"I"
],
[
"C",
"l",
"a",
"s",
"s",
" ",
"I"
]
] |
Enforcement Report - Week of August 15, 2012
|
Classification
|
http://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=Expand+Index&w=08152012%E2%8C%A9=eng
|
0/1438042988061.16_20150728002308-00106-ip-10-236-191-2_271589034_0.json
|
03ba9f5b_port___Week_of_August_15__2012__Classification
|
[Product Type] Devices [Product Description] AngioDynamics Angiographic catheter --- Soft-Vu (JB-1) Non-braided. --- Size: 5F; Length: 100cm; designed to accept guidewire: .035 in. --- Catalog No. [REF]: 10734201. Packaged in boxes of 5 catheters each, with manufacturer listed as AngioDynamics, Inc., Queensbury, NY USA. Intended use: angiographic diagnosis. [Code Info] Lot: 564325 [Reason for Recall] AngioDynamics is recalling one lot of Soft-Vu Angiographic catheters because one of the catheter pouches within the outer box may be mislabeled. [Recalling Firm] Angiodynamics Worldwide Headquarters [Classification]
|
Class II
|
[
[
"C",
"l",
"a",
"s",
"s",
" ",
"I",
"I"
],
[
"C",
"l",
"a",
"s",
"s",
" ",
"I",
"I",
"I"
],
[
"C",
"l",
"a",
"s",
"s",
" ",
"I"
]
] |
Enforcement Report - Week of August 15, 2012
|
Classification
|
http://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=Expand+Index&w=08152012%E2%8C%A9=eng
|
0/1438042988061.16_20150728002308-00106-ip-10-236-191-2_271589034_0.json
|
03ba9f5b_port___Week_of_August_15__2012__Classification
|
[Product Type] Biologics [Product Description] Plasma Frozen within 24 hours (FP24) [Code Info] W047011067810 [Reason for Recall] Blood products, collected from a donor who was previously deferred for a history of intravenous drug use, were distributed. [Recalling Firm] New York Blood Center, Inc. [Classification]
|
Class II
|
[
[
"C",
"l",
"a",
"s",
"s",
" ",
"I",
"I"
],
[
"C",
"l",
"a",
"s",
"s",
" ",
"I",
"I",
"I"
],
[
"C",
"l",
"a",
"s",
"s",
" ",
"I"
]
] |
Enforcement Report - Week of August 15, 2012
|
Classification
|
http://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=Expand+Index&w=08152012%E2%8C%A9=eng
|
0/1438042988061.16_20150728002308-00106-ip-10-236-191-2_271589034_0.json
|
03ba9f5b_port___Week_of_August_15__2012__Classification
|
[Product Type] Biologics [Product Description] Red Blood Cells (Apheresis) Leukocytes Reduced [Code Info] W047011067810 [Reason for Recall] Blood products, collected from a donor who was previously deferred for a history of intravenous drug use, were distributed. [Recalling Firm] New York Blood Center, Inc. [Classification]
|
Class II
|
[
[
"C",
"l",
"a",
"s",
"s",
" ",
"I",
"I"
],
[
"C",
"l",
"a",
"s",
"s",
" ",
"I",
"I",
"I"
],
[
"C",
"l",
"a",
"s",
"s",
" ",
"I"
]
] |
Enforcement Report - Week of August 15, 2012
|
Classification
|
http://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=Expand+Index&w=08152012%E2%8C%A9=eng
|
0/1438042988061.16_20150728002308-00106-ip-10-236-191-2_271589034_0.json
|
03ba9f5b_port___Week_of_August_15__2012__Classification
|
[Product Type] Biologics [Product Description] Red Blood Cells Leukocytes Reduced [Code Info] W038111305828 [Reason for Recall] Blood product, collected from a therapeutic donor with a history of polycythemia vera, was distributed. [Recalling Firm] Florida's Blood Centers, Inc. [Classification]
|
Class III
|
[
[
"C",
"l",
"a",
"s",
"s",
" ",
"I",
"I"
],
[
"C",
"l",
"a",
"s",
"s",
" ",
"I",
"I",
"I"
],
[
"C",
"l",
"a",
"s",
"s",
" ",
"I"
]
] |
Enforcement Report - Week of August 15, 2012
|
Classification
|
http://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=Expand+Index&w=08152012%E2%8C%A9=eng
|
0/1438042988061.16_20150728002308-00106-ip-10-236-191-2_271589034_0.json
|
03ba9f5b_port___Week_of_August_15__2012__Classification
|
[Product Type] Biologics [Product Description] Source Plasma [Code Info] 3270188347, 3270187833, 3270186174, 3270185904, 3270184947, 3270209668, 3270209101, 3270208775, 3270208200, 3270207880, 3270207303, 3270206968, 3270206410, 3270206106, 3270205543, 3270205233, 3270204604, 3270204322, 3270203751, 3270203417, 3270202882, 3270202560, 3270202006, 3270201709, 3270201150, 3270200829, 3270200273, 3270199969, 3270199389, 3270199089, 3270198499, 3270198181, 3270197543, 3270197188, 3270196532, 3270196114, 3270195019, 3270194450, 3270193990, 3270193500, 3270191564, 3270190082, 3270188723, 3270187148, 3270185258, 3270192964, 3270192093, 3270191039, 3270190592, 3270189609, ... More [Reason for Recall] Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed. [Recalling Firm] Talecris Plasma Resources, Inc. [Classification]
|
Class III
|
[
[
"C",
"l",
"a",
"s",
"s",
" ",
"I",
"I"
],
[
"C",
"l",
"a",
"s",
"s",
" ",
"I",
"I",
"I"
],
[
"C",
"l",
"a",
"s",
"s",
" ",
"I"
]
] |
Enforcement Report - Week of August 15, 2012
|
Classification
|
http://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=Expand+Index&w=08152012%E2%8C%A9=eng
|
0/1438042988061.16_20150728002308-00106-ip-10-236-191-2_271589034_0.json
|
03ba9f5b_port___Week_of_August_15__2012__Classification
|
[Product Type] Biologics [Product Description] Red Blood Cells, Irradiated, Leukocytes Reduced, Plasma Reduced [Code Info] W051512035031 [Reason for Recall] Blood product, labeled with an extended expiration date, was distributed. [Recalling Firm] Memorial Blood Centers [Classification]
|
Class III
|
[
[
"C",
"l",
"a",
"s",
"s",
" ",
"I",
"I"
],
[
"C",
"l",
"a",
"s",
"s",
" ",
"I",
"I",
"I"
],
[
"C",
"l",
"a",
"s",
"s",
" ",
"I"
]
] |
Enforcement Report - Week of August 15, 2012
|
Classification
|
http://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=Expand+Index&w=08152012%E2%8C%A9=eng
|
0/1438042988061.16_20150728002308-00106-ip-10-236-191-2_271589034_0.json
|
03ba9f5b_port___Week_of_August_15__2012__Classification
|
[Product Type] Biologics [Product Description] Red Blood Cells Leukocytes Reduced Irradiated [Code Info] W051512006389 [Reason for Recall] Blood product, collected from a donor who traveled to an area considered endemic for malaria, was distributed. [Recalling Firm] Memorial Blood Centers [Classification]
|
Class II
|
[
[
"C",
"l",
"a",
"s",
"s",
" ",
"I",
"I"
],
[
"C",
"l",
"a",
"s",
"s",
" ",
"I",
"I",
"I"
],
[
"C",
"l",
"a",
"s",
"s",
" ",
"I"
]
] |
Enforcement Report - Week of August 15, 2012
|
Classification
|
http://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=Expand+Index&w=08152012%E2%8C%A9=eng
|
0/1438042988061.16_20150728002308-00106-ip-10-236-191-2_271589034_0.json
|
03ba9f5b_port___Week_of_August_15__2012__Classification
|
[Product Type] Devices [Product Description] ***REF IFNT611***Full OSSEOTITE Tapered Certain Implant 6 x 11.5mm***Sterile by radiation***Rx Only***BIOMET 3i Dental Iberica S.L. WTC Almeda Park, Ed, 1, Planta 1 Pl. de la Pau s/n08940 Cornella de Llobregat (Barcelona) Spain. Lot #2011110798. Intended for surgical placement in the upper or lower jaw to provide a means for prosthetic attachment in single tooth restorations and in partially or fully endentulous spans with multiple single teeth utilizing delayed or immediate loading or with a terminal or intermediary abutment for fixed or removable bridge work and to retain over dentures. [Code Info] Lot Number 2011110798 [Reason for Recall] Biomet 3i is recalling their product Full Osseotite Tapered Certain Implant IFNT611. The depth of the implant's internal hex is too shallow. The condition, if present, may prevent the driver; cover screw or abutment from fully engaging the implant. [Recalling Firm] Biomet 3i, LLC [Classification]
|
Class II
|
[
[
"C",
"l",
"a",
"s",
"s",
" ",
"I",
"I"
],
[
"C",
"l",
"a",
"s",
"s",
" ",
"I",
"I",
"I"
],
[
"C",
"l",
"a",
"s",
"s",
" ",
"I"
]
] |
Enforcement Report - Week of August 15, 2012
|
Classification
|
http://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=Expand+Index&w=08152012%E2%8C%A9=eng
|
0/1438042988061.16_20150728002308-00106-ip-10-236-191-2_271589034_0.json
|
03ba9f5b_port___Week_of_August_15__2012__Classification
|
[Product Type] Devices [Product Description] CrossFT Punch, Product Number PFT-45M. Manufacturer: CONMED LINVATEC. The intended use is to create a hole to facilitate insertion of the CrossFT suture anchor into bone. [Code Info] Lot #156920 [Reason for Recall] ConMed Linvatec recalled lot number #156920, PFT-45M, CrossFT Punch because there is a possibility that the device was etched incorrectly listing the item number as PFT-00M and includes incorrect depth lines for insertion. [Recalling Firm] Linvatec Corp. dba ConMed Linvatec [Classification]
|
Class II
|
[
[
"C",
"l",
"a",
"s",
"s",
" ",
"I",
"I"
],
[
"C",
"l",
"a",
"s",
"s",
" ",
"I",
"I",
"I"
],
[
"C",
"l",
"a",
"s",
"s",
" ",
"I"
]
] |
Enforcement Report - Week of August 15, 2012
|
Classification
|
http://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=Expand+Index&w=08152012%E2%8C%A9=eng
|
0/1438042988061.16_20150728002308-00106-ip-10-236-191-2_271589034_0.json
|
03ba9f5b_port___Week_of_August_15__2012__Classification
|
[Product Type] Devices [Product Description] Siemens syngo(R) Lab Data Manager. The syngo(R) Lab Data Manager is classified as a data calculator and processing module for use with In-vitro diagnostic devices. It also provides work flow management as well as remote instrument control to multiple interfaced instruments [Code Info] Version VA11B and all previously released versions. [Reason for Recall] The recalling firm has discovered that when using a Sysmex(R) CA-7000 or CA-1500 coagulation analyzer with the syngo Lab Data Manager (LDM), there is a potential for the syngo LDM system, to display and transmit to the LIS an incorrect result following the syngo LDM's application of the configured result number format. The problem is encountered when the result number format configured on the Sysmex(R) CA-7000 or CA-1500 coagulation analyzer does not match the syngo LDM settings. [Recalling Firm] Siemens Healthcare Diagnostics, Inc. [Classification]
|
Class II
|
[
[
"C",
"l",
"a",
"s",
"s",
" ",
"I",
"I"
],
[
"C",
"l",
"a",
"s",
"s",
" ",
"I",
"I",
"I"
],
[
"C",
"l",
"a",
"s",
"s",
" ",
"I"
]
] |
Enforcement Report - Week of August 15, 2012
|
Classification
|
http://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=Expand+Index&w=08152012%E2%8C%A9=eng
|
0/1438042988061.16_20150728002308-00106-ip-10-236-191-2_271589034_0.json
|
03ba9f5b_port___Week_of_August_15__2012__Classification
|
[Product Type] Biologics [Product Description] Plasma Frozen Cryoprecipitated Reduced [Code Info] 2487825 [Reason for Recall] Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed. [Recalling Firm] South Texas Blood & Tissue Center [Classification]
|
Class II
|
[
[
"C",
"l",
"a",
"s",
"s",
" ",
"I",
"I"
],
[
"C",
"l",
"a",
"s",
"s",
" ",
"I",
"I",
"I"
],
[
"C",
"l",
"a",
"s",
"s",
" ",
"I"
]
] |
Enforcement Report - Week of August 15, 2012
|
Classification
|
http://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=Expand+Index&w=08152012%E2%8C%A9=eng
|
0/1438042988061.16_20150728002308-00106-ip-10-236-191-2_271589034_0.json
|
03ba9f5b_port___Week_of_August_15__2012__Classification
|
[Product Type] Biologics [Product Description] Cryoprecipitated AHF, Pooled [Code Info] 2424507, 2487825 [Reason for Recall] Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed. [Recalling Firm] South Texas Blood & Tissue Center [Classification]
|
Class II
|
[
[
"C",
"l",
"a",
"s",
"s",
" ",
"I",
"I"
],
[
"C",
"l",
"a",
"s",
"s",
" ",
"I",
"I",
"I"
],
[
"C",
"l",
"a",
"s",
"s",
" ",
"I"
]
] |
Enforcement Report - Week of August 15, 2012
|
Classification
|
http://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=Expand+Index&w=08152012%E2%8C%A9=eng
|
0/1438042988061.16_20150728002308-00106-ip-10-236-191-2_271589034_0.json
|
03ba9f5b_port___Week_of_August_15__2012__Classification
|
[Product Type] Biologics [Product Description] Fresh Frozen Plasma [Code Info] 2590622, 2699615, 2522388 [Reason for Recall] Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed. [Recalling Firm] South Texas Blood & Tissue Center [Classification]
|
Class II
|
[
[
"C",
"l",
"a",
"s",
"s",
" ",
"I",
"I"
],
[
"C",
"l",
"a",
"s",
"s",
" ",
"I",
"I",
"I"
],
[
"C",
"l",
"a",
"s",
"s",
" ",
"I"
]
] |
Enforcement Report - Week of August 15, 2012
|
Classification
|
http://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=Expand+Index&w=08152012%E2%8C%A9=eng
|
0/1438042988061.16_20150728002308-00106-ip-10-236-191-2_271589034_0.json
|
03ba9f5b_port___Week_of_August_15__2012__Classification
|
[Product Type] Biologics [Product Description] Recovered Plasma [Code Info] 2386094, 2424507, 2459485, 2613407, 2555602 [Reason for Recall] Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed. [Recalling Firm] South Texas Blood & Tissue Center [Classification]
|
Class II
|
[
[
"C",
"l",
"a",
"s",
"s",
" ",
"I",
"I"
],
[
"C",
"l",
"a",
"s",
"s",
" ",
"I",
"I",
"I"
],
[
"C",
"l",
"a",
"s",
"s",
" ",
"I"
]
] |
Enforcement Report - Week of August 15, 2012
|
Classification
|
http://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=Expand+Index&w=08152012%E2%8C%A9=eng
|
0/1438042988061.16_20150728002308-00106-ip-10-236-191-2_271589034_0.json
|
03ba9f5b_port___Week_of_August_15__2012__Classification
|
[Product Type] Biologics [Product Description] Red Blood Cells Leukocytes Reduced [Code Info] 2386094, 2424507, 2459485, 2487825, 2522388, 2555602, 2590622, 2699615 [Reason for Recall] Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed. [Recalling Firm] South Texas Blood & Tissue Center [Classification]
|
Class II
|
[
[
"C",
"l",
"a",
"s",
"s",
" ",
"I",
"I"
],
[
"C",
"l",
"a",
"s",
"s",
" ",
"I",
"I",
"I"
],
[
"C",
"l",
"a",
"s",
"s",
" ",
"I"
]
] |
Enforcement Report - Week of August 15, 2012
|
Classification
|
http://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=Expand+Index&w=08152012%E2%8C%A9=eng
|
0/1438042988061.16_20150728002308-00106-ip-10-236-191-2_271589034_0.json
|
03ba9f5b_port___Week_of_August_15__2012__Classification
|
[Product Type] Biologics [Product Description] Red Blood Cells (Apheresis) Leukocytes Reduced [Code Info] 6325565 (2 units) [Reason for Recall] Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed. [Recalling Firm] South Texas Blood & Tissue Center [Classification]
|
Class II
|
[
[
"C",
"l",
"a",
"s",
"s",
" ",
"I",
"I"
],
[
"C",
"l",
"a",
"s",
"s",
" ",
"I",
"I",
"I"
],
[
"C",
"l",
"a",
"s",
"s",
" ",
"I"
]
] |
Enforcement Report - Week of August 15, 2012
|
Classification
|
http://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=Expand+Index&w=08152012%E2%8C%A9=eng
|
0/1438042988061.16_20150728002308-00106-ip-10-236-191-2_271589034_0.json
|
03ba9f5b_port___Week_of_August_15__2012__Classification
|
[Product Type] Devices [Product Description] Radiological Image Processing System The system is an aid to locate anatomical structures during open or percutaneous surgical procedures. It is indicated for use in medical conditions that may benefit from the use of stereotactic surgical technique. The system provides a reference to rigid anatomical structures such as sinus, skull, long bone, or vertebra, which are visible on medical images such as CS, MR, or X-ray. [Code Info] E9-0002-G, ES-0013-G, E9-0036-G, E9-0040-G, E9-0041-G, ES-0014-G, ES-0016-G, ES-0033-G, ES-0043-G, ES-0041-G, ES-0042-G, ES-OO84-G, ES-0086-G, ES-0163-G, E9-0089-G, ES-0026-G, ES-0044-G [Reason for Recall] The FluoroTrak Spinal Navigation Application on the OEC 9900 EliteNAV could result in an incorrect position of the navigated instrument(s) versus the displayed reference image. [Recalling Firm] GE OEC Medical Systems, Inc [Classification]
|
Class I
|
[
[
"C",
"l",
"a",
"s",
"s",
" ",
"I",
"I"
],
[
"C",
"l",
"a",
"s",
"s",
" ",
"I",
"I",
"I"
],
[
"C",
"l",
"a",
"s",
"s",
" ",
"I"
]
] |
Enforcement Report - Week of August 15, 2012
|
Classification
|
http://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=Expand+Index&w=08152012%E2%8C%A9=eng
|
0/1438042988061.16_20150728002308-00106-ip-10-236-191-2_271589034_0.json
|
03ba9f5b_port___Week_of_August_15__2012__Classification
|
[Product Type] Devices [Product Description] Stryker Reliance AL Implant Blocker (Various sizes) Manufactured by: Stryker Spine SAS Z1 Marticot-33610-Cestas-France +33 ()) 5.57.97.08.30 http://www.stryker.com Distributed in the USA by: STryker Spine 2 Pearl Court Allendale NJ 07401-1677 USA +1-201-760-8000 The SLIDE Implant Blocker is a reusable instrument, sterilized prior to use. It allows the surgeon to distract the disc space in the lumbar region of the spine using an anterior or anterolateral approach while also allowing them to insert the implant into final position. [Code Info] Catalog Number: 48361223, 48361224, 48361225, 48361226, 48361227, 48361228 Lot Code: 084505, 084506, 084507, 084508, 084509, 084510 [Reason for Recall] Stryker Spine has received six reports regarding the breakage of one or more prongs at the extremity of the instrument. [Recalling Firm] Stryker Spine [Classification]
|
Class II
|
[
[
"C",
"l",
"a",
"s",
"s",
" ",
"I",
"I"
],
[
"C",
"l",
"a",
"s",
"s",
" ",
"I",
"I",
"I"
],
[
"C",
"l",
"a",
"s",
"s",
" ",
"I"
]
] |
Enforcement Report - Week of August 15, 2012
|
Classification
|
http://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=Expand+Index&w=08152012%E2%8C%A9=eng
|
0/1438042988061.16_20150728002308-00106-ip-10-236-191-2_271589034_0.json
|
03ba9f5b_port___Week_of_August_15__2012__Classification
|
[Product Type] Drugs [Product Description] Meloxicam Tablets, USP, 15 mg, Rx Only, 100 Tablets per Bottle, Manufactured by: Strides Acrolab Ltd., Bangalore-560 076, India, Manufactured for: Apotex Corp., Weston, FL 33326, NDC 60505-3579-1. [Code Info] Lot: 7212558, Exp 12/12. [Reason for Recall] Tablet Thickness: Recall was initiated due to the presence of one slightly oversized tablet in a bottle of the identified lot. [Recalling Firm] Apotex Corp. [Classification]
|
Class II
|
[
[
"C",
"l",
"a",
"s",
"s",
" ",
"I",
"I"
],
[
"C",
"l",
"a",
"s",
"s",
" ",
"I",
"I",
"I"
],
[
"C",
"l",
"a",
"s",
"s",
" ",
"I"
]
] |
Enforcement Report - Week of August 15, 2012
|
Classification
|
http://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=Expand+Index&w=08152012%E2%8C%A9=eng
|
0/1438042988061.16_20150728002308-00106-ip-10-236-191-2_271589034_0.json
|
03ba9f5b_port___Week_of_August_15__2012__Classification
|
[Product Type] Devices [Product Description] System 1 base 100/120V The Terumo Advanced Perfusion System 1 is indicated for use in extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures only when used by a qualified perfusionist who is experienced in the operation of Sarns or similar equipment. [Code Info] catalog number: 801763 and serial numbers: 0011-0335, 0337-0610,1001-1034, 1037-1049,1100,1103-1106,1109-1450, and 1452. [Reason for Recall] Terumo Cardiovascular Systems sent a Safety Advisory (AA-2010-007-C) on December 2, 2010 (Recall# Z-0882/0883-2011 RES 57416) regarding malfunctions of the Occluder and Air Bubble Detection (ABD) Modules to a confined number of Terumo Advanced Perfusion System 1 users. The investigation of the malfunction found a faulty component on the modules' application board caused the failures. Terumo CVS replaced all modules in the affected population. Terumo CVS has subsequently received two additional reports of similar malfunctions. The ensuing investigation concluded that, though highly unlikely, it is possible for the same component to fail in any module. Therefore, Terumo CVS is sending a Safety Advisory (with the same instruction as was provided in AA-2010-007-C) to all Terumo System 1 users and is updating the Operator's Manual with instructions on how to respond to a failure. [Recalling Firm] Terumo Cardiovascular Systems Corporation [Classification]
|
Class II
|
[
[
"C",
"l",
"a",
"s",
"s",
" ",
"I",
"I"
],
[
"C",
"l",
"a",
"s",
"s",
" ",
"I",
"I",
"I"
],
[
"C",
"l",
"a",
"s",
"s",
" ",
"I"
]
] |
Enforcement Report - Week of August 15, 2012
|
Classification
|
http://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=Expand+Index&w=08152012%E2%8C%A9=eng
|
0/1438042988061.16_20150728002308-00106-ip-10-236-191-2_271589034_0.json
|
03ba9f5b_port___Week_of_August_15__2012__Classification
|
[Product Type] Devices [Product Description] System 1 base 220/240V The Terumo Advanced Perfusion System 1 is indicated for use in extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures only when used by a qualified perfusionist who is experienced in the operation of Sarns or similar equipment. [Code Info] catalog number: 801764 and serial numbers: 0006-0066, 0100-0311, 0313-0322, 1001-1027, 1100-1434, 1436, 1440, and 1441. [Reason for Recall] Terumo Cardiovascular Systems sent a Safety Advisory (AA-2010-007-C) on December 2, 2010 (Recall# Z-0882/0883-2011 RES 57416) regarding malfunctions of the Occluder and Air Bubble Detection (ABD) Modules to a confined number of Terumo Advanced Perfusion System 1 users. The investigation of the malfunction found a faulty component on the modules' application board caused the failures. Terumo CVS replaced all modules in the affected population. Terumo CVS has subsequently received two additional reports of similar malfunctions. The ensuing investigation concluded that, though highly unlikely, it is possible for the same component to fail in any module. Therefore, Terumo CVS is sending a Safety Advisory (with the same instruction as was provided in AA-2010-007-C) to all Terumo System 1 users and is updating the Operator's Manual with instructions on how to respond to a failure. [Recalling Firm] Terumo Cardiovascular Systems Corporation [Classification]
|
Class II
|
[
[
"C",
"l",
"a",
"s",
"s",
" ",
"I",
"I"
],
[
"C",
"l",
"a",
"s",
"s",
" ",
"I",
"I",
"I"
],
[
"C",
"l",
"a",
"s",
"s",
" ",
"I"
]
] |
Enforcement Report - Week of August 15, 2012
|
Classification
|
http://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=Expand+Index&w=08152012%E2%8C%A9=eng
|
0/1438042988061.16_20150728002308-00106-ip-10-236-191-2_271589034_0.json
|
03ba9f5b_port___Week_of_August_15__2012__Classification
|
[Product Type] Devices [Product Description] EasyLink(TM) Informatics System, Part Number 1000034805. EasyLink(TM) Informatics System is classified as a data calculator and processing module for use with In-Vitro diagnostics devices. [Code Info] Version 5.0 and Version 5.0 Service Pack 1 through 4 [Reason for Recall] There is a potential for the EasyLink system to display and transmit to the Laboratory Information System networks an incorrect result following the EasyLink systems application of the configured result number format. The problem is encountered when the result number format configured on the Sysmex CA-7000 or CA-1500 coagulation analyzer does not match the EasyLink system settings on the following page. [Recalling Firm] Siemens Healthcare Diagnostics, Inc. [Classification]
|
Class II
|
[
[
"C",
"l",
"a",
"s",
"s",
" ",
"I",
"I"
],
[
"C",
"l",
"a",
"s",
"s",
" ",
"I",
"I",
"I"
],
[
"C",
"l",
"a",
"s",
"s",
" ",
"I"
]
] |
Enforcement Report - Week of August 15, 2012
|
Classification
|
http://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=Expand+Index&w=08152012%E2%8C%A9=eng
|
0/1438042988061.16_20150728002308-00106-ip-10-236-191-2_271589034_0.json
|
03ba9f5b_port___Week_of_August_15__2012__Classification
|
[Product Type] Devices [Product Description] cobas KRAS Mutation Test for In Vitro Diagnostic Use Product Usage: Usage: The cobas KRAS Mutation Test, for use with the cobas 4800 System, is a real-time PCR test intended for the identification of mutations in codons 12, 13 and 61 of the KRAS gene in DNA derived from formalin-fixed paraffin-embedded human colorectal cancer (CRC). [Code Info] 05852170190; Lot P06778 [Reason for Recall] During the real-time stability testing for the cobas KRAS Mutation Test on the commercial lot PO6778, it was identified that the kit was just within specifications for the codon 61 peak height ratio, and that the kit has trended towards the upper specification limit at the 6 month time point but did passed the 6 month stability testing. The kit is labeled for 9 months shelf life stability. The data shows that the commercial kits are degrading at an accelerated rate when compared to pilot lots. The degradation will lead to an increased rate of invalid results but will not cause incorrect calls. [Recalling Firm] Roche Molecular Systems, Inc. [Classification]
|
Class III
|
[
[
"C",
"l",
"a",
"s",
"s",
" ",
"I",
"I"
],
[
"C",
"l",
"a",
"s",
"s",
" ",
"I",
"I",
"I"
],
[
"C",
"l",
"a",
"s",
"s",
" ",
"I"
]
] |
Enforcement Report - Week of August 15, 2012
|
Classification
|
http://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=Expand+Index&w=08152012%E2%8C%A9=eng
|
0/1438042988061.16_20150728002308-00106-ip-10-236-191-2_271589034_0.json
|
03ba9f5b_port___Week_of_August_15__2012__Classification
|
[Product Type] Devices [Product Description] TANGO3 Water Storage Tank with Ozone Disinfection System, Tango3, LLC, 132 Citizens Blvd., Simpsonville, KY 40067. Models are WOZ-250-PE, WOZ-240-SS, WOZ-180-SS. The TANGO3 Water Storage Tank with Ozone Disinfection System is intended to be used for disinfection of the water distribution system of a dialysis facility. [Code Info] Model WOZ -250-PE, Serial #s: 1031, 1032, 1033, 1035, 1036, 1038, 1039, 1042, 1043, 1044, 1045, 1046, 1047, 1048, 1049, 1050, 1051, 1053, 1054, 1055, 1056, 1057, 1058, 1059, 1060, 1061, 1062, 1063, 1065, 1066, 1067, 1068, 1069, 1070, 1071, 1072, 1073, 1074, 1075, 1076 & 1077. Model WOZ-180-SS, Serial #s: ... More [Reason for Recall] During an FDA inspection, the firm was notified of Quality System deficiencies, which included lack of procedures for design control and customized modifications that were either not reviewed or received proper clearance from FDA. There was no assurance that all systems in the field were working properly and operating at a minimum of 0.2ppm of ozone. [Recalling Firm] Tango3 LLC [Classification]
|
Class II
|
[
[
"C",
"l",
"a",
"s",
"s",
" ",
"I",
"I"
],
[
"C",
"l",
"a",
"s",
"s",
" ",
"I",
"I",
"I"
],
[
"C",
"l",
"a",
"s",
"s",
" ",
"I"
]
] |
Enforcement Report - Week of August 15, 2012
|
Classification
|
http://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=Expand+Index&w=08152012%E2%8C%A9=eng
|
0/1438042988061.16_20150728002308-00106-ip-10-236-191-2_271589034_0.json
|
03ba9f5b_port___Week_of_August_15__2012__Classification
|
[Product Type] Devices [Product Description] Smith & Nephew 5.5 mm TWINFIX Ultra Ti Suture Anchor with two #2 ULTRABRAID sutures (blue, blue-COBRAID) with Needles Product Usage: intended for use for the reattachment of soft tissue to bone Part Number: 72202618 [Code Info] Lot Numbers: 50396501, 50396505, 50396506, 50397570, 50408062, 50412964, 50416842: [Reason for Recall] Distal part of the anchor may break on insertion into bone during surgery [Recalling Firm] Smith & Nephew, Inc. Endoscopy Division [Classification]
|
Class II
|
[
[
"C",
"l",
"a",
"s",
"s",
" ",
"I",
"I"
],
[
"C",
"l",
"a",
"s",
"s",
" ",
"I",
"I",
"I"
],
[
"C",
"l",
"a",
"s",
"s",
" ",
"I"
]
] |
Enforcement Report - Week of August 15, 2012
|
Classification
|
http://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=Expand+Index&w=08152012%E2%8C%A9=eng
|
0/1438042988061.16_20150728002308-00106-ip-10-236-191-2_271589034_0.json
|
03ba9f5b_port___Week_of_August_15__2012__Classification
|
[Product Type] Devices [Product Description] Smith & Nephew 5.5 mm TWINFIX Ultra Ti Anchor with two #2 sutures(white, COBRAID-blue), sterile Part Number: 72202895 Product Usage: intended for use for the reattachment of soft tissue to bone [Code Info] Lot Numbers: 50388181, 50389102, 50392406, 50394176, 50395679, 50395801, 50399411, 50400927, 50402475, 50403491, 50407007, 50410403, 50412883, 50414234, 50415663, 50416800, 50418329, 50419173, 50421006, 50422555 [Reason for Recall] Distal part of the anchor may break on insertion into bone during surgery [Recalling Firm] Smith & Nephew, Inc. Endoscopy Division [Classification]
|
Class II
|
[
[
"C",
"l",
"a",
"s",
"s",
" ",
"I",
"I"
],
[
"C",
"l",
"a",
"s",
"s",
" ",
"I",
"I",
"I"
],
[
"C",
"l",
"a",
"s",
"s",
" ",
"I"
]
] |
Enforcement Report - Week of August 15, 2012
|
Classification
|
http://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=Expand+Index&w=08152012%E2%8C%A9=eng
|
0/1438042988061.16_20150728002308-00106-ip-10-236-191-2_271589034_0.json
|
03ba9f5b_port___Week_of_August_15__2012__Classification
|
[Product Type] Devices [Product Description] Smith & Nephew 5.5 mm TWINFIX Ultra Ti Anchor with two #2 sutures (COBRAID-blue, COBRAIDblack), sterile Part Number: 72202896 Product Usage: intended for use for the reattachment of soft tissue to bone [Code Info] Lot Numbers: 50388182, 50389253, 50391626, 50392272, 50392407, 50395081, 50395680, 50396197, 50400556, 50401558, 50402228, 50403940, 50406036, 50407582, 50409406, 50413407, 50414970, 50412647, 50415864, 50416801, 50418088, 50420654, 50421030, 50421495 [Reason for Recall] Distal part of the anchor may break on insertion into bone during surgery [Recalling Firm] Smith & Nephew, Inc. Endoscopy Division [Classification]
|
Class II
|
[
[
"C",
"l",
"a",
"s",
"s",
" ",
"I",
"I"
],
[
"C",
"l",
"a",
"s",
"s",
" ",
"I",
"I",
"I"
],
[
"C",
"l",
"a",
"s",
"s",
" ",
"I"
]
] |
Enforcement Report - Week of August 15, 2012
|
Classification
|
http://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=Expand+Index&w=08152012%E2%8C%A9=eng
|
0/1438042988061.16_20150728002308-00106-ip-10-236-191-2_271589034_0.json
|
03ba9f5b_port___Week_of_August_15__2012__Classification
|
[Product Type] Devices [Product Description] Smith & Nephew 5.5 mm TWINFIX Ultra Ti Anchor with three #2 sutures (white, COBRAID- blue), sterile Part Number: 72202897 Product Usage: intended for use for the reattachment of soft tissue to bone [Code Info] Lot Numbers: 50388188, 50389268, 50392431, 50393764, 50394899, 50395675, 50396849, 50397464, 50398727, 50399817, 50400184, 50402082, 50403278, 50405085, 50406197, 50406805, 50408994, 50410001, 50412043, 50412967, 50414260, 50415224, 50416542, 50415681, 50417216, 50418491, 50420660, 50421624 [Reason for Recall] Distal part of the anchor may break on insertion into bone during surgery [Recalling Firm] Smith & Nephew, Inc. Endoscopy Division [Classification]
|
Class II
|
[
[
"C",
"l",
"a",
"s",
"s",
" ",
"I",
"I"
],
[
"C",
"l",
"a",
"s",
"s",
" ",
"I",
"I",
"I"
],
[
"C",
"l",
"a",
"s",
"s",
" ",
"I"
]
] |
Enforcement Report - Week of August 15, 2012
|
Classification
|
http://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=Expand+Index&w=08152012%E2%8C%A9=eng
|
0/1438042988061.16_20150728002308-00106-ip-10-236-191-2_271589034_0.json
|
03ba9f5b_port___Week_of_August_15__2012__Classification
|
[Product Type] Devices [Product Description] i-Stat cTnl cartridges Abbott Point of Care Inc. Abbott Park, IL 60064 USA The i-Stat cTnl test is an in vitro diagnostic test for the quantitative measurement of cardiac troponin I in heparinized whole blood or plasma samples. Cardiac troponin I measurements can be used as an aid in the diagnosis and treatment of myocardial infarction and in the risk stratification of patients with acute coronary syndromes with respect to their relative risk of mortality. The cartridge is to be used with the i-Stat Analyzer, but not with the i-Stat Portable Clinical Analyzer or the Philips Medical System (formerly Agilent Technologies) Blood Analysis Module (BAM). As part of the i-Stat System, the cTnl test is to be used by trained health care professionals in accordance with a facility's policies and procedures. [Code Info] List number 06F15-03, 06F15-04, 03P90-23, 600-9009-25 All lots [Reason for Recall] Abbott Point of Care has determined that the frequency of suppressed results for i-Stat cTnl, BNP and CK-MP cartridges is affected by atmospheric pressure. [Recalling Firm] Abbott Point Of Care Inc. [Classification]
|
Class II
|
[
[
"C",
"l",
"a",
"s",
"s",
" ",
"I",
"I"
],
[
"C",
"l",
"a",
"s",
"s",
" ",
"I",
"I",
"I"
],
[
"C",
"l",
"a",
"s",
"s",
" ",
"I"
]
] |
Enforcement Report - Week of August 15, 2012
|
Classification
|
http://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=Expand+Index&w=08152012%E2%8C%A9=eng
|
0/1438042988061.16_20150728002308-00106-ip-10-236-191-2_271589034_0.json
|
03ba9f5b_port___Week_of_August_15__2012__Classification
|
[Product Type] Devices [Product Description] i-Stat BNP cartridges Abbott Point of Care Inc. Abbott Park, IL 60064 USA The i-Stat BNP test is an in vitro diagnostic test for the quantitative measurement of B-type Natriuertic Peptide (BNP) in whole blood or plasma samples using EDTA as the anticoagulant. BNP measurements can be used as an aid in the diagnosis and assessment of the severity of congestive heart failure. [Code Info] List number 06F30-01, 06F30-02, 03P93-25, 600-9010-25 All lots [Reason for Recall] Abbott Point of Care has determined that the frequency of suppressed results for i-Stat cTnl, BNP and CK-MP cartridges is affected by atmospheric pressure. [Recalling Firm] Abbott Point Of Care Inc. [Classification]
|
Class II
|
[
[
"C",
"l",
"a",
"s",
"s",
" ",
"I",
"I"
],
[
"C",
"l",
"a",
"s",
"s",
" ",
"I",
"I",
"I"
],
[
"C",
"l",
"a",
"s",
"s",
" ",
"I"
]
] |
Enforcement Report - Week of August 15, 2012
|
Classification
|
http://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=Expand+Index&w=08152012%E2%8C%A9=eng
|
0/1438042988061.16_20150728002308-00106-ip-10-236-191-2_271589034_0.json
|
03ba9f5b_port___Week_of_August_15__2012__Classification
|
[Product Type] Devices [Product Description] i-Stat CK-MP cartridges Abbott Point of Care Inc. Abbott Park, IL 60064 USA The i-Stat CKMB test is an in vitro diagnostic test for the quantitative measurement of creatinine kinase MB mass in whole blood or plasma samples. CK-MB measurements can be used as an aid in the diagnosis and treatment of myocardial infarction (MI). [Code Info] List number 06F25-01, 06F25-02, 03P92-25, All lots [Reason for Recall] Abbott Point of Care has determined that the frequency of suppressed results for i-Stat cTnl, BNP and CK-MP cartridges is affected by atmospheric pressure. [Recalling Firm] Abbott Point Of Care Inc. [Classification]
|
Class II
|
[
[
"C",
"l",
"a",
"s",
"s",
" ",
"I",
"I"
],
[
"C",
"l",
"a",
"s",
"s",
" ",
"I",
"I",
"I"
],
[
"C",
"l",
"a",
"s",
"s",
" ",
"I"
]
] |
Enforcement Report - Week of August 15, 2012
|
Classification
|
http://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=Expand+Index&w=08152012%E2%8C%A9=eng
|
0/1438042988061.16_20150728002308-00106-ip-10-236-191-2_271589034_0.json
|
03ba9f5b_port___Week_of_August_15__2012__Classification
|
[Product Type] Devices [Product Description] Model 731 EMV+ Uni-Vent, Impact Instrumentation Inc., 27 Fairfield Place, West Caldwell NJ 07006. Indicated for use in the management of acute or chronic respiratory failure or during resuscitation by providing continuous positive -pressure ventilation. [Code Info] Serial numbers: VCDB120315, VCDB120316, VCDB120299, VCDB120300, VCDB120313, VCDB120307, VCDB120312, VCDB120303, VCDB120310, VCDB120297. [Reason for Recall] Ten units of Model EMV+ Devices were shipped out in error before the verification and validation was completed for a new integrated circuit (IC) on the CPU PCB. [Recalling Firm] Impact Instrumentation, Inc. [Classification]
|
Class III
|
[
[
"C",
"l",
"a",
"s",
"s",
" ",
"I",
"I"
],
[
"C",
"l",
"a",
"s",
"s",
" ",
"I",
"I",
"I"
],
[
"C",
"l",
"a",
"s",
"s",
" ",
"I"
]
] |
Enforcement Report - Week of August 15, 2012
|
Classification
|
http://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=Expand+Index&w=08152012%E2%8C%A9=eng
|
0/1438042988061.16_20150728002308-00106-ip-10-236-191-2_271589034_0.json
|
03ba9f5b_port___Week_of_August_15__2012__Classification
|
[Product Type] Devices [Product Description] I-STAT PT/INR cartridge Abbott Point of Care Inc. Abbott Park, IL 60064 USA This cartridge is useful for monitoring patients receiving oral anticoagulation therapy such as Coumadin or warfarin. [Code Info] List number 04J50-01 04J5O-02 03P89-24 Lots begininng with R11 or R12 [Reason for Recall] The i-STAT PT/INR cartridges have the potential to exhibit incorrectly elevated results. [Recalling Firm] Abbott Point Of Care Inc. [Classification]
|
Class II
|
[
[
"C",
"l",
"a",
"s",
"s",
" ",
"I",
"I"
],
[
"C",
"l",
"a",
"s",
"s",
" ",
"I",
"I",
"I"
],
[
"C",
"l",
"a",
"s",
"s",
" ",
"I"
]
] |
Enforcement Report - Week of August 15, 2012
|
Classification
|
http://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=Expand+Index&w=08152012%E2%8C%A9=eng
|
0/1438042988061.16_20150728002308-00106-ip-10-236-191-2_271589034_0.json
|
03ba9f5b_port___Week_of_August_15__2012__Classification
|
[Product Type] Food [Product Description] Maya Kaimal All Natural Coconut Curry Indian Simmer Sauce, Net Wt 15 oz, Medium, Coconut Milk & Ginger (refrigerated product in flexible plastic tub) [Code Info] Use by code 08/16/12, UPC 89175600037 [Reason for Recall] Product is being recalled due to bloated containers. [Recalling Firm] Two Chefs On A Roll, Inc [Classification]
|
Class II
|
[
[
"C",
"l",
"a",
"s",
"s",
" ",
"I",
"I"
],
[
"C",
"l",
"a",
"s",
"s",
" ",
"I",
"I",
"I"
],
[
"C",
"l",
"a",
"s",
"s",
" ",
"I"
]
] |
Enforcement Report - Week of August 15, 2012
|
Classification
|
http://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=Expand+Index&w=08152012%E2%8C%A9=eng
|
0/1438042988061.16_20150728002308-00106-ip-10-236-191-2_271589034_0.json
|
03ba9f5b_port___Week_of_August_15__2012__Classification
|
[Product Type] Devices [Product Description] Philips MultiDiagnost Eleva with Flat Detector (MD Eleva FD)Model: 708034 Product Usage: Philips X-ray System [Code Info] US Serial Numbers: 96 104 111 120 170 222 223 272 278 WW: 41 70 83 96 104 111 120 132 154 155 156 157 167 170 171 176 179 190 194 195 200 208 216 222 223 224 237 244 245 247 248 249 251 253 259 261 262 264 265 272 278 [Reason for Recall] When doing a 3 Dimensional Rotational Angiography (3DRA) the 3D reconstruction does not always start, even when all images have been acquired. [Recalling Firm] Philips Healthcare Inc. [Classification]
|
Class II
|
[
[
"C",
"l",
"a",
"s",
"s",
" ",
"I",
"I"
],
[
"C",
"l",
"a",
"s",
"s",
" ",
"I",
"I",
"I"
],
[
"C",
"l",
"a",
"s",
"s",
" ",
"I"
]
] |
Enforcement Report - Week of August 15, 2012
|
Classification
|
http://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=Expand+Index&w=08152012%E2%8C%A9=eng
|
0/1438042988061.16_20150728002308-00106-ip-10-236-191-2_271589034_0.json
|
03ba9f5b_port___Week_of_August_15__2012__Classification
|
[Product Type] Devices [Product Description] Finapres Medical Systems Portapres with NiMh battery pack Product Usage: Continuously measure blood pressure, The Portapres can be worn on the body with a protective waist belt. The device can be used without mains; in that case a battery pack is used. [Code Info] Serial Numbers: 12 02 006, 12 02 008, 12 02 013 [Reason for Recall] Battery may become hot and leak [Recalling Firm] FMS, Finapres Medical Systems BV [Classification]
|
Class II
|
[
[
"C",
"l",
"a",
"s",
"s",
" ",
"I",
"I"
],
[
"C",
"l",
"a",
"s",
"s",
" ",
"I",
"I",
"I"
],
[
"C",
"l",
"a",
"s",
"s",
" ",
"I"
]
] |
Enforcement Report - Week of August 15, 2012
|
Classification
|
http://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=Expand+Index&w=08152012%E2%8C%A9=eng
|
0/1438042988061.16_20150728002308-00106-ip-10-236-191-2_271589034_0.json
|
03ba9f5b_port___Week_of_August_15__2012__Classification
|
[Product Type] Devices [Product Description] AUTOMIX High Speed Compounder System, product 2M8077; automated nutrition compounders; Product Usage: The Automix Compounder Systems are electromechanical positive displacement fluid compounding devices used in the admixture of large volume parenteral nutrition formulations via gravimetric weighing. [Code Info] Product code 2M8077, all serial numbers [Reason for Recall] After fluid ingress into the keypad of the AUTOMIX Compounder's (AUTOMIX) control module, the AUTOMIX may generate an incorrect device response to an AUTOMIX operator's key press. Also, the AUTOMIX system may experience an intermittent electrical failure, in which unexpected pump motor operations will occur. Also, the AUTOMIX system may intermittently experience an electrical failure where the compounder may stop compounding without an alarm and not be detected by the user. [Recalling Firm] Baxter Healthcare Corp. [Classification]
|
Class I
|
[
[
"C",
"l",
"a",
"s",
"s",
" ",
"I",
"I"
],
[
"C",
"l",
"a",
"s",
"s",
" ",
"I",
"I",
"I"
],
[
"C",
"l",
"a",
"s",
"s",
" ",
"I"
]
] |
Enforcement Report - Week of August 15, 2012
|
Classification
|
http://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=Expand+Index&w=08152012%E2%8C%A9=eng
|
0/1438042988061.16_20150728002308-00106-ip-10-236-191-2_271589034_0.json
|
03ba9f5b_port___Week_of_August_15__2012__Classification
|
[Product Type] Devices [Product Description] AUTOMIX Plus High Speed Compounder System, product 2M8075; automated nutrition compounders; Product Usage: The Automix Compounder Systems are electromechanical positive displacement fluid compounding devices used in the admixture of large volume parenteral nutrition formulations via gravimetric weighing. [Code Info] Product code 2M8075, all serial numbers [Reason for Recall] After fluid ingress into the keypad of the AUTOMIX Compounder's (AUTOMIX) control module, the AUTOMIX may generate an incorrect device response to an AUTOMIX operator's key press. Also, the AUTOMIX system may experience an intermittent electrical failure, in which unexpected pump motor operations will occur. Also, the AUTOMIX system may intermittently experience an electrical failure where the compounder may stop compounding without an alarm and not be detected by the user. [Recalling Firm] Baxter Healthcare Corp. [Classification]
|
Class I
|
[
[
"C",
"l",
"a",
"s",
"s",
" ",
"I",
"I"
],
[
"C",
"l",
"a",
"s",
"s",
" ",
"I",
"I",
"I"
],
[
"C",
"l",
"a",
"s",
"s",
" ",
"I"
]
] |
Enforcement Report - Week of August 15, 2012
|
Classification
|
http://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=Expand+Index&w=08152012%E2%8C%A9=eng
|
0/1438042988061.16_20150728002308-00106-ip-10-236-191-2_271589034_0.json
|
03ba9f5b_port___Week_of_August_15__2012__Classification
|
[Product Type] Devices [Product Description] AUTOMIX 3+3 Compounder System, product 2M8286 (115V) and 2M8286K (230V), automated nutrition compounders; Product Usage: The Automix Compounder Systems are electromechanical positive displacement fluid compounding devices used in the admixture of large volume parenteral nutrition formulations via gravimetric weighing. [Code Info] Product codes 2M8286 and 2M8286K, all serial numbers [Reason for Recall] After fluid ingress into the keypad of the AUTOMIX Compounder's (AUTOMIX) control module, the AUTOMIX may generate an incorrect device response to an AUTOMIX operator's key press. Also, the AUTOMIX system may experience an intermittent electrical failure, in which unexpected pump motor operations will occur. Also, the AUTOMIX system may intermittently experience an electrical failure where the compounder may stop compounding without an alarm and not be detected by the user. [Recalling Firm] Baxter Healthcare Corp. [Classification]
|
Class I
|
[
[
"C",
"l",
"a",
"s",
"s",
" ",
"I",
"I"
],
[
"C",
"l",
"a",
"s",
"s",
" ",
"I",
"I",
"I"
],
[
"C",
"l",
"a",
"s",
"s",
" ",
"I"
]
] |
Enforcement Report - Week of August 15, 2012
|
Classification
|
http://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=Expand+Index&w=08152012%E2%8C%A9=eng
|
0/1438042988061.16_20150728002308-00106-ip-10-236-191-2_271589034_0.json
|
03ba9f5b_port___Week_of_August_15__2012__Classification
|
[Product Type] Devices [Product Description] AUTOMIX 3+3 Compounder with Accusource Monitoring System, product 2M8287; automated nutrition compounders; Product Usage: The Automix Compounder Systems are electromechanical positive displacement fluid compounding devices used in the admixture of large volume parenteral nutrition formulations via gravimetric weighing. [Code Info] Product code 2M8287, all serial numbers [Reason for Recall] After fluid ingress into the keypad of the AUTOMIX Compounder's (AUTOMIX) control module, the AUTOMIX may generate an incorrect device response to an AUTOMIX operator's key press. Also, the AUTOMIX system may experience an intermittent electrical failure, in which unexpected pump motor operations will occur. Also, the AUTOMIX system may intermittently experience an electrical failure where the compounder may stop compounding without an alarm and not be detected by the user. [Recalling Firm] Baxter Healthcare Corp. [Classification]
|
Class I
|
[
[
"C",
"l",
"a",
"s",
"s",
" ",
"I",
"I"
],
[
"C",
"l",
"a",
"s",
"s",
" ",
"I",
"I",
"I"
],
[
"C",
"l",
"a",
"s",
"s",
" ",
"I"
]
] |
Enforcement Report - Week of August 15, 2012
|
Classification
|
http://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=Expand+Index&w=08152012%E2%8C%A9=eng
|
0/1438042988061.16_20150728002308-00106-ip-10-236-191-2_271589034_0.json
|
03ba9f5b_port___Week_of_August_15__2012__Classification
|
[Product Type] Devices [Product Description] djo surgical Screw 6.5 mm, Sz 25mm, low profile. Product is intended for the fixation of the acetabular shell or fracture repair [Code Info] Lot 007A1037, Ref 010-55-25. [Reason for Recall] One lot of the 010-55-030, 6.5 mm Cancellous Bone Screw was recalled because a product complaint identified a mislabeling of the device. Although the package label indicates Size 30mm, the screw dimension is actually 25mm. [Recalling Firm] Encore Medical, Lp [Classification]
|
Class II
|
[
[
"C",
"l",
"a",
"s",
"s",
" ",
"I",
"I"
],
[
"C",
"l",
"a",
"s",
"s",
" ",
"I",
"I",
"I"
],
[
"C",
"l",
"a",
"s",
"s",
" ",
"I"
]
] |
Enforcement Report - Week of August 15, 2012
|
Classification
|
http://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=Expand+Index&w=08152012%E2%8C%A9=eng
|
0/1438042988061.16_20150728002308-00106-ip-10-236-191-2_271589034_0.json
|
Subsets and Splits
No community queries yet
The top public SQL queries from the community will appear here once available.