Recall Z-0284-2009 ยท FMI Needle, Hypodermic, Single Lumen
Covidien LP
ReliOn Insulin syringes - 1cc, 31 G Distributed by: Can-Am Care, Corp., Alpharetta, GA
| Date | Nov 5, 2008 (initiated Oct 9, 2008) |
| Status | Terminated |
| Reason | 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. |
| Root cause | 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 | 471,000 (4710 boxes of 100) |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K033373 | MONOJECT INSULIN SYRINGE Tyco Healthcare, Nov 13, 2003 |