Olympus Corporation of the Americas Recall 92129
Description: 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
Olympus Corporation of the Americas Recall 92129 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1615-2023 |
| Event ID | 92129 |
| Event Description | 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 |
| Product Type | Devices |
| Distribution | Natiowide Foreign: Canada, Germany |
| Quantity | 2058 (Boxes; 5 per Box) |
| Recall 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. |
| Device Classification | 20230531 |
| Device Code Info | UDI: 04953170388248 Lot numbers: KR243729 KR248648 KR248652 KR248673 KR248784 KR248785 KR248808 KR249160 KR251593 KR257313 KR257314 KR264662 KR264697 KR264708 KR264711 KR264726 KR264732 KR264746 KR264751 KR264778 KR264806 KR276770 |
| Center Classification Date | 20230519 |
| Recall Initiation Date | 20230331 |
| Recalling Firm | Olympus Corporation of the Americas |
| Initial Notification | Letter |
| Similar To |