Drug recall
Regard. Item number: 830034. GS0348D- CVC Triple Lumen 20CM non Sulfa-Mercy.
FDA recall event 85591 · Class II · ROi CPS LLC
Key facts
| Event ID | 85591 |
|---|---|
| Recall numbers | Z-2265-2020 |
| Recalling firm | ROi CPS LLC |
| Product type | Devices |
| Products | Regard. Item number: 830034. GS0348D- CVC Triple Lumen 20CM non Sulfa-Mercy. |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Custom procedure kits contains affected lots of PosiFlush Syringe, a product recalled by BD. |
| Initiation date | Apr 20, 2020 |
| Report date | Jun 17, 2020 |
| Termination date | Aug 21, 2020 |
| 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: