Recall Z-2401-2023 ยท KNY Accessories, Catheter, G-U
Olympus Corporation of the Americas
UroPass Ureteral Access Sheaths, 5 pieces/box
| Date | Aug 14, 2023 (initiated May 19, 2023) |
| Status | Open, Classified |
| Reason | Dilator tips may break in the package and in patients during surgical procedures. |
| Root cause | Nonconforming Material/Component |
| Action | 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. |
| Quantity | 9520 eaches |
| Distribution | Worldwide distribution - United States Nationwide and the countries of South Korea, Canada, Australia, Taiwan, Hong Kong, Japan, and Germany. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K051593 | UROPASS URETERAL ACCESS SHEATH, MODEL 61224 Acmi Corporation, Sep 2, 2005 |