Recall Z-1957-2019 ยท HIH Hysteroscope (And Accessories)
Richard Wolf Medical Instruments Corp.
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 combination with endoscopic accessories, for examination, diagnosis, and/or therapy in various medical
| Date | Jun 13, 2019 (initiated May 23, 2019) |
| Status | Terminated |
| Reason | E-Line Cutting Electrode package 8416.0305 contains E-Line Hook Electrode 8416.09 instead of E-Line Cutting Electrode 8416.03. |
| Root cause | Under Investigation by firm |
| Action | Richard Wolf Medical Instruments, Corp. notified customers on 05/23/2019 via "Urgent Safety Information: Recall" letter. Instructions included to examine distribution reports and stock immediately to determine if any affected devices are on hand, quarantine any affected devices, advise customers of the recall if affected devices were further distributed, and scrap all affected devices on site. Customers were also instructed to complete and return the Answer form provided with the notification letter. An updated "Urgent Safety Information: Recall" letter was sent via email on 06/07/2019 to c |
| Quantity | 5 boxes (5 electrodes each) |
| Distribution | US nationwide distribution in the states of South Carolina, Rhode Island, and Missouri. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K980302 | WORKING ELEMENTS, RESECTOSCOPE SHEATHS, ELECTRODES, OBTURATORS, ENDOSCOPES Richard Wolf Medical Instruments Corp., Jul 20, 1998 |