; and (2) a Class I or Class II recall is issued by the Food and Drug Administration for any drug or device that is manufactured or processed at such facility. (b) Duration (1) Banned facilities with Class I recall For a banned facility for which a Class I recall is issued as described in subsection (a)(2): (A) The designation of the banned facility pursuant to an order under subsection (a), based on an initial Class I recall of a drug or device manufactured or processed at the facility, shall be in effect for the 10-year period beginning on the date that is one year after the issuance of the order. (B) The designation of the banned facility pursuant to an order under subsection (a), based on a subsequent Class I recall of a drug or device manufactured or processed at the facility, shall be in effect permanently beginning on the date that is one year after the issuance of such order. (2) Banned facilities with Class II recall For a banned facility for which a class II recall is issued as described in subsection (a)(2): (A) The designation of the banned facility pursuant to an order under subsection (a), based on an initial Class II recall of a drug or device manufactured or processed at the facility, shall be in effect for the 5-year period beginning on the date that is one year after the issuance of the order. (B) The designation of the banned facility pursuant to an order under subsection (a), based on a first subsequent Class II recall of a drug or device manufactured or processed at the facility, may be renewed to be in effect for a period of 5 years beginning— (i) if the initial 5-year period under subparagraph (A) has concluded, one year from the date of the first subsequent recall