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Vaccines, Blood & Biologics

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Recall of RAD-SURE Blood Irradiation Indicators-International Specialty Products / Kent Adhesive Products Company

DATE RECALL INITIATED:

July 21, 2006

PRODUCT / LOT NUMBER / EXPIR

RAD-SURE XR Lot Number O15811XR September 2007
RAD-SURE XR Lot Number O15816XR October 2007

International Distribution:

RAD-SURE X-15 Lot Number O15811X15 September 2007
RAD-SURE X-15 Lot Number O15814X15 October 2007
RAD-SURE X-15 Lot Number O15819X15 November 2007
RAD-SURE X-15 Lot Number O15823X15 December 2007

RECALLING FIRM:

International Specialty Products (ISP)
Wayne, New Jersey

MANUFACTURER:

Kent Adhesive Products Company
Kent, Ohio

REASON:

ISP received two complaints from customers in which certain indicators from these lots failed to turn completely black after being irradiated. ISP believes that a portion of the active film laminate in these lots was exposed to excessive heat during the manufacturing process. Customers are asked to contact ISP to arrange for product return.

    
 

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  • Consumer Affairs Branch (CBER)

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    Office of Communication, Outreach and Development

    Food and Drug Administration

    1401 Rockville Pike

    Suite 200N/HFM-47

    Rockville, MD 20852-1448

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