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DATE RECALL INITIATED:
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.
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.
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