Device recall
Z-1185-2023: Finished Goods Box of 50 Inserts and Scanning Labels for Medivac Guardian 3L…
FDA device recall · Class II · Stryker Corporation
Key facts
| Recall number (Z-number) | Z-1185-2023 |
|---|---|
| Recall event | 91578 |
| Product | Finished Goods Box of 50 Inserts and Scanning Labels for Medivac Guardian 3L Catalog Number: FG 12022. Intended adjunct in the estimation of blood loss. |
| Product code | PBZ |
| Recalling firm | Stryker Corporation |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K142801 |
| FEI number | 3015967359 |
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