Recall Z-1423-2023 ยท FCL Forceps, Biopsy, Non-Electric
Richard Wolf GmbH
FLEX. BIOPSY FORCEPS 5FR WL 550MM, Product Number 829.051
| Date | Apr 24, 2023 (initiated Mar 24, 2023) |
| Status | Open, Classified |
| Reason | Potentially unable to open forceps jaws when the endoscope shaft is bent by about 90 degrees. If, in addition, the proximal forceps shaft is bent, the forceps can no longer be opened or restrictions begin even with a slight bending of the endoscope. |
| Root cause | Under Investigation by firm |
| Action | The firm issued an Urgent Medical Device Correction notice on 03/24/2023 to its consignees by USPS certified mail. The notice explained the issue and explained the proper use of the device to avoid exposing patients to improper handling. Richard Wolf is already optimizing the forceps design. Further batches of these forceps can be used with the expected maximum flexibility. The procedure described in the notice does not expose patients to risks from jaw sections that do not open. The firm issued a follow up letter titled, Urgent Medical Device Removal beginning on 08/02/2023, via USPS certi |
| Quantity | 342 units |
| Distribution | Worldwide distribution - US Nationwide and the countries of United Arab Emirates (AE), Argentina (AR), Austria (AT), Belgium (BE), BO, Brazil (BR), Canada (CA), Chile (CL), Czech Republic (CZ), Germany (DE), Denmark (DK), Ecuador (EC), Spain (ES), Finland (FI), France (FR), Greece (GR), Hong Kong (H |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K971315 | AUXILIARY INSTRUMENTS FOR URS Richard Wolf Medical Instruments Corp., Sep 15, 1997 |