Device recall
Z-1957-2019: E-Line Cutting Electrode 11.5Fr Mono 0 degrees, Sterile. One electrode is placed…
FDA device recall · Class II · Richard Wolf Medical Instruments Corp.
Key facts
| Recall number (Z-number) | Z-1957-2019 |
|---|---|
| Recall event | 82946 |
| Product | E-Line Cutting Electrode 11.5Fr Mono 0 degrees, Sterile. One electrode is placed in a plastic tray and then inserted into a Tyvek pouch. Five packaged electrodes are placed in a white box. Product Usage: Resectoscopes are used for endoscopically controlled ablation of tissue. They are used, in… |
| Product code | HIH |
| Recalling firm | Richard Wolf Medical Instruments Corp. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 4, 2020 |
| 510(k) numbers | K980302 |
| FEI number | 1418479 |
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