Device recall
Z-2643-2020: LoFric Origo, Nelaton, 16in, FR10 urinary catheters
FDA device recall · Class II · Wellspect HealthCare (Division of DENTSPLY IH AB)
Key facts
| Recall number (Z-number) | Z-2643-2020 |
|---|---|
| Recall event | 85905 |
| Product | LoFric Origo, Nelaton, 16in, FR10 urinary catheters |
| Product code | EZD |
| Recalling firm | Wellspect HealthCare (Division of DENTSPLY IH AB) |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 9, 2021 |
| 510(k) numbers | K122078 |
| FEI number | 3009632672 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 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