ReliOn Insulin syringes - 1cc, 31 G Distributed by: Can-Am Care, Corp., Alpharetta, GA
FDA device recall Z-0284-2009 · posted 2008-11-05 · Terminated
Recall details
- Recalling firm
- Covidien LP
- 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 taken
- 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.
- Root cause
- Process design
- Status
- Terminated
- Product code
- FMI
- Quantity affected
- 471,000 (4710 boxes of 100)
- Distribution
- Nationwide
- Date initiated
- 2008-10-09
- Date posted
- 2008-11-05
- Date terminated
- 2010-07-06
- Location
- Mansfield, MA
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MONOJECT INSULIN SYRINGE (K033373) | Tyco Healthcare | 2003-11-13 |