Device recall
Z-1250-2022: Regard Item Number: 800214007 Sterile GS00367 - GASTRO BYPASS - SPARTANBURG…
FDA device recall · Class II · ROi CPS LLC
Key facts
| Recall number (Z-number) | Z-1250-2022 |
|---|---|
| Recall event | 90135 |
| Product | Regard Item Number: 800214007 Sterile GS00367 - GASTRO BYPASS - SPARTANBURG. CONMED Catalog No. 60-5274-944-Needle w/ Stealth ER, 44cm, 5mm |
| Product code | FDE |
| Recalling firm | ROi CPS LLC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 31, 2024 |
| 510(k) numbers | K952204 |
| FEI number | 3014527682 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 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