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DATE RECALL INITIATED: May 11, 1999
PRODUCT / LOT NUMBER / EXPIRATION DATE:
GZ80804 08/04/1999
FX80616 06/16/1999
GW80529 05/29/1999
FZ81201 12/01/1999
The following lots are currently expired, but still subject to recall:
FZ80430 04/30/1999
GY71230 12/30/1998
GW80428 04/28/1999
FW80206 02/06/1999
FW80305 03/05/1999
FW80505 05/05/1999
FY80403 04/03/1999
FZ80306 03/06/1999
FZ80323 03/23/1999
FZ80327 03/27/1999
FZ80428 04/28/1999
GX80505 05/05/1999
FZ80427 04/27/1999
FE70918 09/18/1998
GZ71210 12/10/1998
MANUFACTURER:
V.I. Technologies, Inc.
Melville, NY
DISTRIBUTOR:
American Red Cross
Arlington, VA
REASON:
V.I. Technologies is voluntarily recalling an additional nineteen lots of PLAS+SD (fifteen of which are expired) 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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