Recall of CS3000 Apheresis Kits
DATE RECALL INITIATED:
June 21, 2007
PRODUCT / LOT NUMBER:
CS 3000 Apheresis Kits (All lot numbers starting with "N")
Product Codes: 4R2180T, 4R2210T
International Distribution: R4R2210T, R4R2230T
MANUFACTURER:
Fenwal, Inc.
Round Lake, IL
REASON:
Fenwal has become aware of two instances where the anticoagulant citrate dextrose (ACD) and saline lines were reversed in the assembly process. The reversed line connections may not be visually apparent in the monitor box, and could result in excessive ACD infusion and severe injury, including death, to the donor. Fenwal will contact its customers to arrange for product return.
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.