Recall Z-1504-2009 ยท FMF Syringe, Piston
Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals
AccuSure, U-100 31 Gauge, 1cc Insulin Syringe, 5/16" (8mm) Needles, Short Needle, packaged 10 syringes per package, 10 packages per carton, NDC 0603-7002-2
| Date | Jun 24, 2009 (initiated Apr 9, 2009) |
| Status | Terminated |
| Reason | Needles separate from the barrel of the syringes. |
| Root cause | Nonconforming Material/Component |
| Action | On 04/09/2009, Qualitest issued a press release and sent out recall notifications to their consignees by US Mail. The recall was extended to the User level. Qualitest will send a second letter to all non-responders after thirty days. Thirty days after the second letter, Qualitest will perform a recall effectiveness check by telephone on a percentage of non-responders (in accordance with FDA request). |
| Quantity | 559,500 syringes |
| Distribution | Nationwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K070917 | FEEL-JECT INSULIN SYRINGE Feel Tech, Jun 20, 2007 |