Z-0284-2009

ReliOn Insulin syringes - 1cc, 31 G Distributed by: Can-Am Care, Corp., Alpharetta, GA

Name: Z-0284-2009 ReliOn Insulin syringes - 1cc, 31 G Distributed by: Can-Am Care, Corp., Alpharetta, GA
Creator: Covidien LP
Published: 2008-10-09
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2008-10-09 / Terminated / root cause: manufacturing process

FDA source

Covidien LP began a recall of ReliOn Insulin syringes - 1cc, 31 G Distributed by: Can-Am Care, Corp., Alpharetta, GA on 2008-10-09. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0284-2009
Status: Terminated
Initiated: 2008-10-09
Posted: 2008-11-05
Terminated: 2010-07-06
Recalling firm: Medtronic, Inc.
Product: ReliOn Insulin syringes - 1cc, 31 G Distributed by: Can-Am Care, Corp., Alpharetta, GA
Product code: FMI Needle, Hypodermic, Single Lumen
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.
Root cause tag: manufacturing process
FDA 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 in commerce: 471,000 (4710 boxes of 100)
Distribution: Nationwide
Product codes and lots: Lot Number 813900 (Lot number is located on packaging for individual syringes)

Product code FMI

K033373Class IIMonoject Insulin SyringeTyco Healthcare / cleared 2003-11-13

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)