Device recall
Z-0368-2024: Curaplex manual resuscitators with integrated manometer, multiple accessory…
FDA device recall · Class II · SunMed Holdings, LLC
Key facts
| Recall number (Z-number) | Z-0368-2024 |
|---|---|
| Recall event | 93237 |
| Product | Curaplex manual resuscitators with integrated manometer, multiple accessory configurations to include: 1. Curaplex Adult Premium BVM with Bag Reservoir, Manometer, Filter, Peep Valve & Mask, REF # 2442-BVMPAD; 2. Curaplex Child Premium BVM with Bag Reservoir, Manometer, 25cm Pop-off, Filter & Mask… |
| Product code | BTM |
| Recalling firm | SunMed Holdings, LLC |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K012842 |
| FEI number | 1314417 |
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