Recall of RAD-SURE Blood Irradiation Indicators

DATE RECALL INITIATED:

July 21, 2006

PRODUCT / LOT NUMBER / EXPIRATION DATE:

RAD-SURE Blood Irradiation Indicators

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.

The information in this listing reflects CBER's best efforts to communicate information that has been reported to FDA. Its accuracy and comprehensiveness cannot be guaranteed.