Device recall
Z-1596-2009: Stat (TM) Super-Fine (TM) Pen Needles and Allison Medical, Inc. Sure Comfort Pen…
FDA device recall · Class II · Stat Medical Devices, Inc.
Key facts
| Recall number (Z-number) | Z-1596-2009 |
|---|---|
| Recall event | 52159 |
| Product | 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. |
| Product code | FMI |
| Recalling firm | Stat Medical Devices, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 7, 2010 |
| FEI number | 1000525253 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database