Device recall
Z-0925-2018: QuikClot TraumaPad, Part# 460 a topical dressing for local management of…
FDA device recall · Class II · Z-Medica, LLC
Key facts
| Recall number (Z-number) | Z-0925-2018 |
|---|---|
| Recall event | 79407 |
| Product | QuikClot TraumaPad, Part# 460 a topical dressing for local management of bleeding wounds such as cuts, lacerations, and abrasions. It may also be used for temporary treatment of severely bleeding wounds such as surgical wounds (operative, postoperative, dermatological, etc.) and traumatic injuries |
| Product code | FRO |
| Recalling firm | Z-Medica, LLC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 4, 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