Device recall
Z-2612-2017: QuikClot TraumaPad,, sterile, soft, white, X-ray detectable hemostatic dressing…
FDA device recall · Class II · Z-Medica, LLC
Key facts
| Recall number (Z-number) | Z-2612-2017 |
|---|---|
| Recall event | 77316 |
| Product | QuikClot TraumaPad, , sterile, soft, white, X-ray detectable hemostatic dressing Part Number 460 Manufactured by Z-Medica, LLC 4 Fairfield Boulevard, Wallingford, CT 06492 USA For use as a topical dressing for local management of bleeding wounds such as cuts, lacerations, and abrasions. It may also… |
| Product code | FRO |
| Recalling firm | Z-Medica, LLC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 15, 2018 |
| 510(k) numbers | K123387 |
| FEI number | 3004138549 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 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