Drug recall
Regard brand CABG Pack A and B - Spartanburg
FDA recall event 89951 · Class II · ROi CPS LLC
Key facts
| Event ID | 89951 |
|---|---|
| Recall numbers | Z-1051-2022 |
| Recalling firm | ROi CPS LLC |
| Product type | Devices |
| Products | Regard brand CABG Pack A and B - Spartanburg |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Kits were packed into shipping boxes incorrectly. |
| Initiation date | Mar 21, 2022 |
| Report date | May 18, 2022 |
| Termination date | Dec 28, 2023 |
| 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: