Recall Z-1694-2012 ยท FMF Syringe, Piston
Covidien LLC
Monoject Insulin Safety Syringe 3/l0mL 29 X 1/2" Product ID: 8881511144 Indications for Use: Injection of U-1 00 insulin
| Date | May 31, 2012 (initiated May 21, 2012) |
| Status | Terminated |
| 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 o |
| Quantity | 952,000 syringes |
| Distribution | Worldwide Distribution - USA (nationwide) and the countries of Canada, Australia, Belgium, and Panama. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K922522 | MONOJECT SAFETY SYRINGE, 1 CC, 3CC AND 12 CC SIZES Sherwood Medical Co., Nov 25, 1992 |