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.