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Olympus Corporation of the Americas recalls ViziShot 2 Single Use Aspiration Needle, 21G- To be used with ultrasound endoscopes for ultrasound guided fine needle as
Recalled May 31, 2023 · FDA recall Z-1615-2023 · Olympus Corporation of the Americas
Hazard
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. · FDA Class III
Units
2058 (Boxes; 5 per Box)
Sold at
Natiowide Foreign: Canada, Germany
Description
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.
Product
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
Manufacturer(s)
Olympus Corporation of the Americas
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →