Device recall
Z-2247-2009: AccuSure, U-100, 31Gauge, 1/2cc Insulin Syringe, 5/16" (8mm), Short Needle, NDC…
FDA device recall · Class II · Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals
Key facts
| Recall number (Z-number) | Z-2247-2009 |
|---|---|
| Recall event | 52849 |
| Product | 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 |
| Product code | FMF |
| Recalling firm | Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Nov 24, 2010 |
| 510(k) numbers | K021197 |
| FEI number | 3003197096 |
At a glance
- 1–9 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