Recall Z-0942-05 ยท FMF Syringe, Piston
Qualitest Pharmaceuticals Inc
AccuSure Insulin Syringe, 1cc, 28 guage, 1/2'', packaged in boxes of 100, each containing 10 bundles of 10 syringes, disposable, NDC 0603-6996-21.
| Date | Jun 30, 2005 (initiated Jun 14, 2005) |
| Status | Terminated |
| Reason | Labeling error. There is a possibility that 1cc syringes are labeled at 1/2cc on the plastic inner wrap holding bundles of 10 syringes. |
| Root cause | Other |
| Action | The firm initiated the recall on June 14, 2005 with a press release and followed with a letter initially sent via fax and then by letter requesting return of the product and posting of a copy of the press release at the retail level. |
| Quantity | unknown |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.