FDA Medical Device Recalls (openFDA)
Covidien LLC: Monoject Insulin Safety Syringe 3/10mL 30 X 5/16" Product ID: 8881511344 Indications for Use: Injection of U-1 00 insulin
- Recall number
- Z-1695-2012
- Recalling firm
- Covidien LLC
- Product
- Monoject Insulin Safety Syringe 3/10mL 30 X 5/16" Product ID: 8881511344 Indications for Use: Injection of U-1 00 insulin
- Status
- Terminated
- Initiated
- 2012-05-21
- Posted
- 2012-05-31
- Terminated
- 2013-06-10
- Reason
- Safety shield may separate from the syringe, exposing the needle, which could potentially result in a needle stick
- 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 sdfeedback@covidien.com. 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:sdfeedback@covidien.com
- Quantity
- 77,500 syringes
- Distribution
- Worldwide Distribution - USA (nationwide) and the countries of Canada, Australia, Belgium, and Panama.
- Lot, serial or model codes
- Lot Code: 019115
- 510(k) numbers
- ["K922522"]
- PMA numbers
- not on file
- Product code
- FMF
- 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