Z-1616-2023 Class III Ongoing
FDA device recall Z-1616-2023 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: 1297 (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
- 1297 (Boxes; 5 per Box)
Product Description
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
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: 04953170388286 Lot numbers: KR248740 KR248746 KR252863 KR253666 KR253681 KR260854 KR260865 KR260873 KR260875 KR260876 KR260877 KR260896 KR260917 KR260937