Recall Z-1616-2023 ยท FCG Biopsy Needle
Olympus Corporation of the Americas
To be used with ultrasound endoscopes for ultrasound guided fine needle aspiration (FNA) of submucosal and extramural lesions of the tracheobronchial tree and the gastrointestinal tract Models: NA-U401SX-4022, NA-U401SX-4022-A
| Date | May 19, 2023 (initiated Mar 31, 2023) |
| Status | Open, Classified |
| Reason | Product non-conformance pertaining to the angle of the needle does not meet manufacturing specifications and remained unbent, resulting to slight resistance experienced during needle advancement and retraction. |
| Root cause | Employee error |
| Action | Olympus issued Urgent Medical Medical Device Recall letter on 3/31/23 to Endoscopy Department, Pulmonology Department; Risk Management. . Letter states reason for recall, health risk and action to take: 1. Immediately locate any affected products listed in this communication and quarantine these products. 2. Contact our Olympus Customer Service Team at 1-800-848-9024, option 2. Olympus will issue a Return Material Authorization to return any affected product at no charge to you. Olympus will issue a credit to your facility upon return of affected product. 3. Olympus requests that you acknowle |
| Quantity | 1297 (Boxes; 5 per Box) |
| Distribution | Natiowide Foreign: Canada, Germany |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K160098 | Single Use Aspiration Needle NA-U401SX Olympus Medical Systems Corp., Mar 22, 2016 |