DATE RECALL INITIATED:
January 7, 2010
PRODUCT / LOT NUMBER / EXPIRATION DATE:
Y-Type Blood Solution Sets
Product Code: 2C8750
Round Lake, IL
During product inspection of Y-Type Blood Solution sets, Baxter observed that some blood filter devices contained fiber-like particulate matter consistent with filter material, in the fluid path below the filter. This particulate matter has the potential to be infused into patients. Although Baxter has received no complaints or reports of adverse events related to this issue, a voluntary recall is being issued as a precautionary measure for Y-type blood filters released from July through September of 2009. Customers are asked to contact the manufacturer 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.