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U.S. Department of Health and Human Services

Class 1 Device Recall ReliOn

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 Class 1 Recall
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Date Posted November 05, 2008
Recall Status1 Terminated on July 06, 2010
Recall Number Z-0284-2009
Recall Event ID 49606
Premarket Notification
510(K) Number
Product Classification Needle, Hypodermic, Single Lumen - Product Code FMI
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/
Covidien LP
15 Hampshire St
Mansfield, Massachusetts 02048-1113
For Additional Information Contact SAME
Manufacturer 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.
FDA Determined
Cause 2
DESIGN: Process Design
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
Total Product Life Cycle TPLC Device Report

1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = FMI and Original Applicant = TYCO HEALTHCARE