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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Recall of Charter Medical Transfer Bags-Charter Medical, Ltd

DATE RECALL INITIATED:

November 21, 2005
 

PRODUCT / LOT NUMBER / EXPIRATION DATE:

100mL Six Bag Aliquot System with piercing pin and injection site
Product Code: T2186
Lot Number: 109851
Expiration Date: March, 2009

MANUFACTURER:

Charter Medical, Ltd
Winston-Salem, NC

REASON:

Charter Medical, Ltd. has initiated a voluntary recall of transfer bags, lot 109851. The T2186 product is comprised of six 100 mL blood aliquot bags connected by a tubing manifold. The label on the outer case states 100 mL bag, which is correct. The labels affixed to the bags, referred to as the volunteer donor labels, state 150 mL, which is incorrect. Use of the device could lead to bag breakage if the bag is overfilled. Consignees have been asked to contact the manufacturer to arrange for product return.

 

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