Device recall
Z-0411-2022: regard Clinical Packaging Solutions Item Number 830096005, OB01054E - Newborn…
FDA device recall · Class II · ROi CPS LLC
Key facts
| Recall number (Z-number) | Z-0411-2022 |
|---|---|
| Recall event | 89078 |
| Product | regard Clinical Packaging Solutions Item Number 830096005, OB01054E - Newborn Kit, containing 2 25GA x .625IN needles. |
| Product code | MLS |
| Recalling firm | ROi CPS LLC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 7, 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