Device recall
Z-0945-2021: Tourni-Cot - Universal, UDI 00855364004085, Model Number TCU, Non-pneumatic…
FDA device recall · Class II · Mar-Med Co
Key facts
| Recall number (Z-number) | Z-0945-2021 |
|---|---|
| Recall event | 87009 |
| Product | Tourni-Cot - Universal, UDI 00855364004085, Model Number TCU, Non-pneumatic Tourniquet - Product Usage: The device is intended to be used in surgery on fingers or toes to provide a blood-less field. |
| Product code | GAX |
| Recalling firm | Mar-Med Co |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 14, 2023 |
| 510(k) numbers | K853472 |
| FEI number | 1832653 |
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