Device recall
Z-1968-2021: SNS Disposable Urethral Catheter Electrode, 10 Fr, Gold Recording/Stimulating…
FDA device recall · Class II · Spes Medica
Key facts
| Recall number (Z-number) | Z-1968-2021 |
|---|---|
| Recall event | 87999 |
| Product | SNS Disposable Urethral Catheter Electrode, 10 Fr, Gold Recording/Stimulating Contact printed on polyurethane film adhesive with attached 2 meter lead-wire with touch-proof connector, Reference Number UE006 |
| Product code | FAP |
| Recalling firm | Spes Medica |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 10, 2022 |
| 510(k) numbers | K113771 |
| FEI number | 3011534533 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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