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DATE RECALL INITIATED: May 4, 1999
PRODUCT / LOT NUMBER / EXPIRATION DATE:
FW80601 06/01/1999
FW80529 05/29/1999
FW80731 07/31/1999
FW80829 08/29/1999
FZ80604 06/04/1999
FZ80805 08/05/1999
GW80514 05/14/1999
GZ80731 07/31/1999
FW80706 07/06/1999
GX80528 05/28/1999
FW80602 06/02/1999
MANUFACTURER:
V.I. Technologies, Inc.
Melville, NY
DISTRIBUTOR:
American Red Cross
Arlington, VA
REASON:
V.I. Technologies is voluntarily recalling an additional eleven lots of PLAS+
SD based on the results of additional testing for parvovirus B19 using validated PCR technology. There has been no evidence of clinical disease typical of parvovirus B19 associated with the transfusion of the above lots of PLAS+ SD.
As noted in the product insert, parvovirus B19 most seriously affects pregnant women or immunocompromised individuals. Therefore, physicians and healthcare practitioners should exercise caution when using this product in these patients. Voluntary recall of these lots is intended to reduce risk from parvovirus B19 infection.
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.
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