Vaccines, Blood & Biologics
Resources for You
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 Us
- (800) 835-4709
- (301) 827-1800
- ocod@fda.hhs.gov
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

