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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
(301) 827-1800
Consumer Affairs Branch (CBER)

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