Z-1615-2023 Class III Ongoing
FDA device recall Z-1615-2023 was initiated by Olympus Corporation of the Americas on March 31, 2023 and is designated Class III. Reason for recall: 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 r… The recall status is ongoing. Affected quantity: 2058 (Boxes; 5 per Box).
Recall Details
- Product Type
- Devices
- Report Date
- May 31, 2023
- Initiation Date
- March 31, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2058 (Boxes; 5 per Box)
Product 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
Reason for Recall
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.
Distribution Pattern
Natiowide Foreign: Canada, Germany
Code Information
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