UroPass Ureteral Access Sheaths, 5 pieces/box
FDA device recall Z-2401-2023 · posted 2023-08-14 · Open, Classified
Recall details
- Recalling firm
- Olympus Corporation of the Americas
- Reason for recall
- Dilator tips may break in the package and in patients during surgical procedures.
- 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.
- Root cause
- Nonconforming Material/Component
- Status
- Open, Classified
- Product code
- KNY
- Quantity affected
- 9520 eaches
- Distribution
- Worldwide distribution - United States Nationwide and the countries of South Korea, Canada, Australia, Taiwan, Hong Kong, Japan, and Germany.
- Date initiated
- 2023-05-19
- Date posted
- 2023-08-14
- Location
- Center Valley, PA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| UROPASS URETERAL ACCESS SHEATH, MODEL 61224 (K051593) | Acmi Corporation | 2005-09-02 |