Recall Z-1596-2009 ยท FMI Needle, Hypodermic, Single Lumen
Stat Medical Devices, Inc.
Stat (TM) Super-Fine (TM) Pen Needles and Allison Medical, Inc. Sure Comfort Pen Needles with Silicone Tip, for human use with insulin pen injector device to administer insulin subcutaneously.
| Date | Jul 24, 2009 (initiated May 29, 2009) |
| Status | Terminated |
| Reason | Stat Pen Needles with silicone coating have not been cleared by FDA for use with silicone coating which could significantly affect the safety and effectiveness of the device. |
| Root cause | PMA |
| Action | An "Urgent: Medical Device Recall Notification" letter dated June 18, 2009 was issued to direct customers requesting return of affected product and requesting they send notification to any customers which may have received the affected product from them. Direct questions about the recall to Stat Medical Devices by calling 1-978-774-1469. |
| Quantity | 6,424,100 total pen needles |
| Distribution | Worldwide Distribution -- US (CO and Puerto Rico), Canada, and Saudi Arabia. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.