Medical Device Notification
TERUFLEX CPDA-1 Blood Bag System
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.
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.