FDA-Device2023-08-23Class II
UroPass Ureteral Access Sheaths, 5 pieces/box
Olympus Corporation of the Americas
Hazard
Dilator tips may break in the package and in patients during surgical procedures.
Sold states
Worldwide distribution - United States Nationwide and the countries of South Korea, Canada, Australia, Taiwan, Hong Kong, Japan, and Germany.
Affected count
9520 eaches
Manufactured in
3500 Corporate Pkwy, Center Valley, PA, United States
Products
UroPass Ureteral Access Sheaths, 5 pieces/box
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2401-2023Don't want to check this manually?
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