Recall Z-1615-2023 ยท FCG Biopsy Needle
Olympus Corporation of the Americas
ViziShot 2 Single Use Aspiration Needle, 21G- 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. Model: NA-U401SX-4021, NA-U401SX-4021-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 | 2058 (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 |