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U.S. Department of Health and Human Services

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.

 

Contact FDA

(800) 835-4709
(301) 827-1800
Consumer Affairs Branch (CBER)

Division of Communication and Consumer Affairs

Office of Communication, Outreach and Development

Food and Drug Administration

1401 Rockville Pike

Suite 200N/HFM-47

Rockville, MD 20852-1448