Device recall
Z-2167-2021: Regard NEWBORN KIT, LD00201j, Item Number: 830016010. Medical convenience kit…
FDA device recall · Class II · ROi CPS LLC
Key facts
| Recall number (Z-number) | Z-2167-2021 |
|---|---|
| Recall event | 88210 |
| Product | Regard NEWBORN KIT, LD00201j, Item Number: 830016010. Medical convenience kit which includes an infant heel warmer. |
| Product code | MLS |
| Recalling firm | ROi CPS LLC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 8, 2023 |
| 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