FDA Medical Device Recalls (openFDA)
Covidien LP: ReliOn Insulin syringes - 1cc, 31 G Distributed by: Can-Am Care, Corp., Alpharetta, GA
- Recall number
- Z-0284-2009
- Recalling firm
- Covidien LP
- Product
- ReliOn Insulin syringes - 1cc, 31 G Distributed by: Can-Am Care, Corp., Alpharetta, GA
- Status
- Terminated
- Initiated
- 2008-10-09
- Posted
- 2008-11-05
- Terminated
- 2010-07-06
- 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
- Lot, serial or model codes
- Lot Number 813900 (Lot number is located on packaging for individual syringes)
- 510(k) numbers
- ["K033373"]
- PMA numbers
- not on file
- Product code
- FMI
- Firm FEI
- 1282497
- Firm city
- Mansfield
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28