FDA-Device2023-05-31Class III
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
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.
Sold states
Natiowide Foreign: Canada, Germany
Affected count
2058 (Boxes; 5 per Box)
Manufactured in
3500 Corporate Pkwy, N/A, Center Valley, PA, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1615-2023Don't want to check this manually?
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