Drug recall
LoFric Origo, Nelaton, 16in, FR10 urinary catheters
FDA recall event 85905 · Class II · Wellspect HealthCare (Division of DENTSPLY IH AB)
Key facts
| Event ID | 85905 |
|---|---|
| Recall numbers | Z-2643-2020, Z-2644-2020, Z-2645-2020 |
| Recalling firm | Wellspect HealthCare (Division of DENTSPLY IH AB) |
| Product type | Devices |
| Products | LoFric Origo, Nelaton, 16in, FR10 urinary catheters, LoFric Origo, Tiemann, 16in, FR12 urinary catheters, LoFric Origo, Tiemann, 16in, FR14 urinary catheters |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Wellspect Healthcare is voluntarily recalling certain LoFric¿ Origo" urethral catheters due to a potential defect which may be present in the catheter s distal tip., Wellspect Healthcare is voluntarily recalling certain LoFric¿ Origo" urethral catheters due to a potential defect which may be present in the catheters distal tip. |
| Initiation date | Jun 17, 2020 |
| Report date | Jul 29, 2020 |
| Termination date | Apr 9, 2021 |
| City | Molndal |
| Country | Sweden |
| FEI number | 3009632672 |
At a glance
- 1–9 Products in this recall
- None 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: