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Medical Device Notification: TERUFLEX CPDA-1 Blood Bag System-Terumo Medical Corporation
DATE INITIATED:
August 1, 2007
PRODUCT:
TERUFLEX Blood Bags with Blood Sampling Arm
CPDA-1 Anticoagulant
450 mL Collection Bag; Triple Blood Bag
PRODUCT CODE: 1BB*TCD456A4
LOT NUMBER: 070418GV
MANUFACTURER:
Terumo Medical Corporation
REASON:
Terumo has initiated a voluntary removal of the TERUFLEX CPDA-1 Blood Bag System because of a noted labeling discrepancy with this product. According to Terumo there have been no patient related incidents, but this could potentially result in mislabeled blood components.
Contact Us
Consumer Affairs Branch (CBER)
- (800) 835-4709
- (301) 827-1800
- ocod@fda.hhs.gov
Division of Communication and Consumer Affairs
Office of Communication, Outreach and Development
Food and Drug Administration
1401 Rockville Pike
Suite 200N/HFM-47
Rockville, MD 20852-1448

