Drug recall
Regard Item Number: 800214007 Sterile GS00367 - GASTRO BYPASS - SPARTANBURG. CONMED Catalog No…
FDA recall event 90135 · Class II · ROi CPS LLC
Key facts
| Event ID | 90135 |
|---|---|
| Recall numbers | Z-1250-2022 |
| Recalling firm | ROi CPS LLC |
| Product type | Devices |
| Products | Regard Item Number: 800214007 Sterile GS00367 - GASTRO BYPASS - SPARTANBURG. CONMED Catalog No. 60-5274-944-Needle w/ Stealth ER, 44cm, 5mm |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Potential for the tip of the electrode to detach during use. |
| Initiation date | May 3, 2022 |
| Report date | Jun 15, 2022 |
| Termination date | May 31, 2024 |
| City | Republic |
| State | MO |
| Country | United States |
| FEI number | 3014527682 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: