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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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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 FDA

(800) 835-4709
(240) 402-8010
Consumer Affairs Branch (CBER)

Division of Communication and Consumer Affairs

Office of Communication, Outreach and Development

Food and Drug Administration

10903 New Hampshire Avenue

Building 71 Room 3103

Silver Spring, MD 20993-0002