Device recall
Z-3183-2024: Kits of Convenience containing 1 of the 2 Item Numbers: 1. Item Number: 59-300…
FDA device recall · Class II · Safeguard US Operating LLC
Key facts
| Recall number (Z-number) | Z-3183-2024 |
|---|---|
| Recall event | 95183 |
| Product | Kits of Convenience containing 1 of the 2 Item Numbers: 1. Item Number: 59-300 HAWK Warming Grid, 2. Item Number: 59-320 HAWK Advanced Hypothermia Management Set. Convenience kits labeled as follows: Combat Life Saver - Intermediate (Product Number: 83-323-CB) contains 59-300 / 1 Each; Medic… |
| Product code | IMD |
| Recalling firm | Safeguard US Operating LLC |
| Recall class | Class II |
| Status | Open, Classified |
| FEI number | 3008258694 |
At a glance
- None 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