Device recall
Z-0365-2024: Ventlab, LLC SafeSpot manual resuscitators with integrated manometer, multiple…
FDA device recall · Class II · SunMed Holdings, LLC
Key facts
| Recall number (Z-number) | Z-0365-2024 |
|---|---|
| Recall event | 93237 |
| Product | Ventlab, LLC SafeSpot manual resuscitators with integrated manometer, multiple accessory configurations to include: 1. SafeSpot Infant Resuscitator REF #s: SS3200OBPC-T, SS3204MB-D12, SS3200MB-2, SS3200MB-D1, SS3200OBP, SS3200MB-MMC, SS3200MBP-M00, SS3200MB-PW, SS3200MBP-2I, SS3200MBF-2… |
| 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