Device product
UroPass Ureteral Access Sheaths, 5 pieces/box
Z-2401-2023
Product summary
- Event
- Event 92495
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 9520 eaches
- Official record key
device-enforcement:Z-2401-2023
Official wording
Reason: Dilator tips may break in the package and in patients during surgical procedures.
Code information: Models: 61024BX, 61038BX, 61046BX, 61054BX, 61124BX, 61138BX, 61146BX, 61154BX, 61224BX, 61238BX, 61246BX, 61254BX, 61324BX, 61338BX, 61346BX, 61354BX Lots: All products manufactured in 2018 and 2019. Manufacturing date is printed on pouch label in YYYY-MM-DD format.
Distribution pattern: Worldwide distribution - United States Nationwide and the countries of South Korea, Canada, Australia, Taiwan, Hong Kong, Japan, and Germany.
Derived failure modes
-
Unknown
Dilator tips may break in the package and in patients during surgical procedures.