Device recall
Z-1047-2025: regard Item Number: 830106006, LD01114F - Newborn Kit containing the component…
FDA device recall · Class I · ROi CPS LLC
Key facts
| Recall number (Z-number) | Z-1047-2025 |
|---|---|
| Recall event | 96094 |
| Product | regard Item Number: 830106006, LD01114F - Newborn Kit containing the component Neo-Tee Resuscitator. Convenience kit to be used in Labor and Delivery. |
| Product code | MLS |
| Recalling firm | ROi CPS LLC |
| Recall class | Class I |
| Status | Open, Classified |
| FEI number | 3014527682 |
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