Recall Z-0364-2025 ยท KNY Accessories, Catheter, G-U
Olympus Corporation of the Americas
Brand Name: UroPass Ureteral Access Sheaths Product Name: Ureteral Access Sheaths Model/Catalog Number: 61024BX, 61038BX, 61046BX, 61054BX, 61124BX, 61138BX, 61146BX, 61154BX, 61224BX, 61238BX, 61246BX, 61254BX, 61324BX, 61338BX, 61346BX, 61354BX Software Version: N/A Product Description: The Olympus UroPass Ureteral Access Sheath Set consists of a hydrophilic coated outer sheath and an inner tape
| Date | Nov 12, 2024 (initiated Sep 11, 2024) |
| Status | Open, Classified |
| Reason | Exposure of the UroPass product to Ultraviolet ( UV ) Radiation can cause brittleness of the device dilator tip, which may lead to broken dilator tips in the package or in patients during surgical procedures. |
| Root cause | Storage |
| Action | ****UPDATE Nov 8, 2024*** Olympus mailed a revision letter-URGENT: MEDICAL DEVICE CORRECTION UPDATED INFORMATION to consignees on November 8, 2024. Letter states; To reduce the risk of UV exposure to your device(s), Olympus instructs users to implement the following actions: Minimize the exposure of UroPass Ureteral Access Sheaths to ultraviolet light. Exposure to UV light during storage periods may cause embrittlement of this device, increasing the potential for breakage and patient injury, including retained device fragments, tissue damage, or perforation of the ureter. Updated Information: |
| Quantity | 14,093 units |
| Distribution | Worldwide distribution - US Nationwide and the countries of Australia, Canada, China, Germany, Hong Kong, Japan, Republic of South Korea, Singapore. |
| 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 |