Monoject Insulin Safety Syringe 1/2mL 29 X 1/2" Product ID: 8881511136 Indications for Use: Injection of U-1 00 insulin
FDA device recall Z-1696-2012 · posted 2012-05-31 · Terminated
Recall details
- Recalling firm
- Covidien LLC
- Reason for recall
- Safety shield may separate from the syringe, exposing the needle, which could potentially result in a needle stick
- Action taken
- 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
- Root cause
- Equipment maintenance
- Status
- Terminated
- Product code
- FMF
- Quantity affected
- 26,655,000 syringes
- Distribution
- Worldwide Distribution - USA (nationwide) and the countries of Canada, Australia, Belgium, and Panama.
- Date initiated
- 2012-05-21
- Date posted
- 2012-05-31
- Date terminated
- 2013-06-10
- Location
- Mansfield, MA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MONOJECT SAFETY SYRINGE, 1 CC, 3CC AND 12 CC SIZES (K922522) | Sherwood Medical Co. | 1992-11-25 |