FDA-Device2023-05-31Class III
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
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
1297 (Boxes; 5 per Box)
Manufactured in
3500 Corporate Pkwy, N/A, Center Valley, PA, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1616-2023Don't want to check this manually?
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