Recall Z-2246-2021 ยท FJL Resectoscope
Richard Wolf GmbH
CUTTING ELECTRODE BIPO 24.5FR, REF 4653.1323
| Date | Jun 25, 2021 |
| Status | Terminated |
| Reason | Product labeled as Cutting Electrode may contain BIVAP electrode. |
| Root cause | Under Investigation by firm |
| Action | The firm notified its importer 06/25/2021 and subsequently initiated the recall by letter (titled URGENT SAFETY INFORMATION) to its consignees on 06/29/2021. The letter explained the issue and the hazard, and requested consignees and user facilities scrap the affected device. |
| Quantity | 20 boxes |
| Distribution | US Nationwide Distribution in the states of CA, CO, IN, MA, NH |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K062720 | S-LINE BIPOLAR RESECTOSCOPES AND BIPOLAR ELECTRODES Richard Wolf Medical Instruments Corp., Mar 22, 2007 |