Recall Z-2247-2009 ยท FMF Syringe, Piston
Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals
AccuSure, U-100, 31Gauge, 1/2cc Insulin Syringe, 5/16" (8mm), Short Needle, NDC 0603-7001-21, packaged 10 syringes per package, 10 packages per carton
| Date | Sep 24, 2009 (initiated Aug 21, 2009) |
| Status | Terminated |
| Reason | Needles separate from the barrels of the syringes |
| Root cause | Nonconforming Material/Component |
| Action | The firm initiated the recall via a press release on 08/21/2009. They began notifying their consignees of the problem and the recall by letter on 08/21/2009. email: recallresponse@qualitestrx.com |
| Quantity | 37,340 boxes of 100 units |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K021197 | SUREONE INSULIN SYRINGE, 31 GAUGE X 5/16 Hosuk Co., Ltd., Apr 26, 2002 |