Recalls / —
—#201158
Product
UroPass Ureteral Access Sheaths, 5 pieces/box
- FDA product code
- KNY — Accessories, Catheter, G-U
- Device class
- Class 2
- Medical specialty
- Gastroenterology, Urology
- 510(k) numbers
- K051593
- Affected 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.
Why it was recalled
Dilator tips may break in the package and in patients during surgical procedures.
Root cause (FDA determination)
Nonconforming Material/Component
Action the firm took
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.
Recalling firm
- Firm
- Olympus Corporation of the Americas
- Address
- 3500 Corporate Pkwy, Center Valley, Pennsylvania 18034-8229
Distribution
- Distribution pattern
- Worldwide distribution - United States Nationwide and the countries of South Korea, Canada, Australia, Taiwan, Hong Kong, Japan, and Germany.
Timeline
- Recall initiated
- 2023-05-19
- Posted by FDA
- 2023-08-14
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #201158. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.