Z-1694-2012

Monoject Insulin Safety Syringe 3/l0mL 29 X 1/2" Product ID: 8881511144 Indications for Use: Injection of U-1...

Name: Z-1694-2012 Monoject Insulin Safety Syringe 3/l0mL 29 X 1/2" Product ID: 8881511144 Indications for Use: Injection of U-1...
Creator: Covidien LLC
Published: 2012-05-21
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2012-05-21 / Terminated / root cause: manufacturing process

FDA source

Covidien LLC began a recall of Monoject Insulin Safety Syringe 3/l0mL 29 X 1/2" Product ID: 8881511144 Indications for Use: Injection of U-1 00 insulin on 2012-05-21. The reason FDA records is "Safety shield may separate from the syringe, exposing the needle, which could potentially result in a needle stick". 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-1694-2012
Status: Terminated
Initiated: 2012-05-21
Posted: 2012-05-31
Terminated: 2013-06-10
Recalling firm: Medtronic, Inc.
Product: Monoject Insulin Safety Syringe 3/l0mL 29 X 1/2" Product ID: 8881511144 Indications for Use: Injection of U-1 00 insulin
Product code: FMF Syringe, Piston
Reason for recall: Safety shield may separate from the syringe, exposing the needle, which could potentially result in a needle stick
Root cause tag: manufacturing process
FDA root cause: Equipment maintenance
Action: Covidien sent an Urgent Product Recall letter dated May 21, 2012, via Federal Express. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately stop using any affected product. Distributors were requested to notify their customers. Customers were instructed to complete the Monoject Insulin Safety Syringe recalled product return form even if they have no product to return. The form should be faxed to 1-800-895-6140 or e-mailed to [email protected]. Customer Service questions regarding the recall please use one of the following methods. Telephone:1-800-722-8772 option I (Weekdays, 8am to 6:30pm Eastern) e-mail:[email protected]
Quantity in commerce: 952,000 syringes
Distribution: Worldwide Distribution - USA (nationwide) and the countries of Canada, Australia, Belgium, and Panama.
Product codes and lots: Lot Codes: 013816, 017007, 019113, 020608, 029905

Product code FMF

K922522Class IIMonoject Safety Syringe, 1 Cc, 3Cc and 12 Cc SizesSherwood Medical Co. / cleared 1992-11-25

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)