Recall Z-2534-2020 ยท FHQ Holder, Needle, Gastroenterologic
Dufner Instrumente GmbH
DUFNER Instrumente GmbH-De Bakey Slim Needleholder- intended to hold a suturing needle for closing wounds during suturing and surgical procedures Reference Number: 18044-23
| Date | Jun 3, 2020 |
| Status | Terminated |
| Reason | Tungsten carbide plate, which is intended to hold the sewing needle securely, can break when holding the sewing needle under pressure and result in in patient tissue injury |
| Root cause | Process control |
| Action | Dufner Instruments GMB issued letter dated June 3, 2020, staing reason for recall, health risk and action to take: 1. Immediately remove all products of the affected article number with the named lots fromyour warehouse or from affected instrument trays to prevent further use. 2. With this letter you will receive a confirmation form, please fill it in completely, sign it and send it back to us after receiving this information. If you do not own any affected products, please fill out the confirmation form anyway and fax it to +49 (0)7461/79419 or mail it to d.moehrle@dufner-tuttlingen.de. 3. |
| Quantity | 30 units |
| Distribution | IL |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.