• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

  • Print
  • Share
  • E-mail

Recall: Y-Type Blood Solution Sets

DATE RECALL INITIATED:

January 7, 2010

PRODUCT / LOT NUMBER / EXPIRATION DATE:

Y-Type Blood Solution Sets

Product Code: 2C8750

Lot Numbers
URO9G21135
URO9H03156
URO9G21094
URO9G31175
UR09H03016
URO9G31043

MANUFACTURER:

Baxter
Round Lake, IL

REASON:

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.