Device recall
Z-0541-2021: Clinical Innovations ROM Plus Collection Kit IFU: ROM Plus Rupture of Membrane…
FDA device recall · Class II · Clinical Innovations, LLC
Key facts
| Recall number (Z-number) | Z-0541-2021 |
|---|---|
| Recall event | 86255 |
| Product | Clinical Innovations ROM Plus Collection Kit IFU: ROM Plus Rupture of Membrane Test ROM-5025, ROM-6025 |
| Product code | NQM |
| Recalling firm | Clinical Innovations, LLC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 24, 2024 |
| 510(k) numbers | K110605 |
| FEI number | 1000220650 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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