Recall of Blood-Pack Unit with PL 732 Transfer Pack
DATE RECALL INITIATED:
November 11, 2002
LOT NUMBERS / EXPIRATION DATES:
M02A08033 9/30/2003
M02A14015 9/30/2003
M02A17042 9/30/2003
M02A10047 9/30/2003
M02A14049 9/30/2003
M02A17034 9/30/2003
M02A21036 9/30/2003
M02A18040 9/30/2003
M02A14056 9/30/2003
M02F28048 2/29/2004
M02G10044 3/31/2004
M02G15035 3/31/2004
M02G17031 3/31/2004
M02G22049 3/31/2004
M02G29010 3/31/2004
M02G31024 3/31/2004
M02G18013 3/31/2004
M02G18039 3/31/2004
M02G25034 3/31/2004
M02G09012 3/31/2004
M02G25042 3/31/2004
M02G29028 3/31/2004
M02G30059 3/31/2004
M02I10016 5/31/2004
M02I27010 5/31/2004
M02I05032 5/31/2004
M02I09034 5/31/2004
M02H01025 4/30/2004
M02H02015 4/30/2004
M02H05034 4/30/2004
M02H07022 4/30/2004
M02H09036 4/30/2004
M02H14028 4/30/2004
M02H16098 4/30/2004
M02H19076 4/30/2004
M02H15041 4/30/2004
MANUFACTURER:
Baxter Health Care Corp/Fenwal
Maricao, Puerto Rico
REASON:
Baxter Health Care has become aware of the splitting of the platelet container during component preparation. This has only been observed during centrifugation or expression of plasma, in which the split occurs near the side of the container. The blood products that have been successfully processed in the containers that did not split are not affected.
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.
Last Updated: 12/16/2002
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