Device recall
Z-1437-2012: ViaSpan Cold Storage Solution 1000mL Bag distributed under the Barr/Duramed…
FDA device recall · Class II · Teva Pharmaceuticals USA, Inc.
Key facts
| Recall number (Z-number) | Z-1437-2012 |
|---|---|
| Recall event | 61622 |
| Product | ViaSpan Cold Storage Solution 1000mL Bag distributed under the Barr/Duramed Pharmaceuticals label (10 x 1000mL bags). Disposable kidney perfusion set. |
| Product code | KDL |
| Recalling firm | Teva Pharmaceuticals USA, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 25, 2012 |
| 510(k) numbers | K944866 |
| FEI number | 2517175 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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