UroPass Ureteral Access Sheaths, 5 pieces/box
This recall is currently active, issued August 14, 2023. It was issued by Olympus Corporation Of The Americas.
- Recall Initiated
- May 19, 2023
- Posted
- August 14, 2023
- Recall Number
- Z-2401-2023
- Quantity
- 9520 eaches
- Firm Location
- Center Valley, PA
- Official Source
- View on FDA website ↗
Reason for Recall
Dilator tips may break in the package and in patients during surgical procedures.
Distribution
Worldwide distribution - United States Nationwide and the countries of South Korea, Canada, Australia, Taiwan, Hong Kong, Japan, and Germany.
Lot / Code Info
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.
Root Cause
Nonconforming Material/Component
Action Taken
A customer notification letter was issued to customers on May 19, 2023. Customers were requested to identify affected product; cease and quarantine any product manufactured prior to December 31, 2019. Acknowledgement of receipt should be made to Olympus per the instructions in the recall letter.