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U.S. Department of Health and Human Services

Medical & Radiation Emitting Device Recalls
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 Class 1 Recall
ReliOn		see related information
Date Posted November 05, 2008
Recall Number Z-0284-2009
Product ReliOn Insulin syringes - 1cc, 31 G Distributed by: Can-Am Care, Corp., Alpharetta, GA
Code Information Lot Number 813900 (Lot number is located on packaging for individual syringes)
Recalling Firm/
Manufacturer		 Covidien LP
15 Hampshire St
Mansfield, Massachusetts 02048-1113
For Additional Information Contact SAME
508-261-8000
Reason for
Recall		 Mislabeled: Package labeled as an insulin syringe for use with U-100 insulin contains an insulin syringe for use with U-40 insulin. Risk of overdose of insulin.
Action Tyco Healthcare Group LP (Covidien) notified Can-Am Care, Corp. by letter sent by e-mail and by Federal Express on 10/9/08. The letter requests that they immediately inventory, quarantine any remaining stock they may have of the product, return, and notify their customers. Wal-Mart conducted a consumer mailing on October 14, 2008, and is posting placards in their stores. Can-Am Care, whose name appears on the label of the product has concurrently posted a recall notice on their website.
Quantity in Commerce 471,000 (4710 boxes of 100)
Distribution Nationwide
 
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