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DATE RECALL INITIATED:
May 7, 2002
PRODUCT / LOT NUMBER / EXPIRATION DATE
Baxter Fenwal Open System Apheresis Kit - H01G23055 2-28-2003
Baxter Fenwal Semi-Closed System Apheresis Kit - H01G09104 3-6-2003
Baxter Fenwal Closed System Apheresis Kit - H01G02117 1-31-2003
RECALLING FIRM
Baxter Healthcare Corporation
Fenwal Division
Round Lake, IL
MANUFACTURER:
Baxter Healthcare Corporation
Mountain Home, AR
REASON:
Baxter Healthcare Corporation has become aware of a restriction in the Y-site located above the separation container that can cause pressure alarms during priming of the Apheresis Kit and possibly during the collection procedure. This restriction may damage red cell during the collection procedure. The CS-3000 Blood Cell Separator is designed to alarm when pressure restrictions occur during priming or the collection procedure. These alarms alert the CS-3000 Operator of a restriction within the Apheresis Kit. The potential issues associated with this restriction are alarms during priming and collection, difficulty completing a procedure, and impaired red blood cell flow. The flow restriction through the Y-site would affect a small number of Apheresis Kits and would be apparent to the CS-3000 operator via alarms during the priming and run procedures. Consignees have been asked to contact the manufacturer to arrange for product return.
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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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