Reported Nov 20, 2024 · Ongoing
Brand Name: UroPass Ureteral Access Sheaths Product Name: Ureteral Access Sheaths Model/Catalog Number: 61024BX,…
Olympus Corporation of the Americas
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Olympus Corporation of the Americas · 3500 Corporate Pkwy · Center Valley, PA · 18034-8229
Is this the product you have?
- Brand NameUroPass
- Ureteral Access Sheaths Product NameUreteral
- Access Sheaths Model/Catalog Number
61024BX61038BX61046BX61054BX61124BX61138BX61146BX61154BX61224BX61238BX61246BX61254BX61324BX61338BX61346BX61354BX
- Software VersionN/A
- Product DescriptionThe Olympus UroPass Ureteral Access Sheath Set consists of a hydrophilic coated outer sheath and an inner tapered dilator intended to establish a conduit for the passage of endoscopes and retrieval devices into the ureter. The hydrophilic coating on the UroPass Ureteral Access Sheath eases passage and placement. Both the outer sheath and inner dilator are radio-opaque for ease of viewing radiographically. Intended for single use only
- ComponentN/A
- Lot codes and dates
- Model/UDI-DI
61024BX/0082192503531761038BX/0082192503532461046BX/0082192503533161054BX/0082192503534861124BX/0082192503535561138BX/0082192503536261146BX/0082192503537961154BX/0082192503538661224BX/0082192503539361238BX/0082192503540961246BX/0082192503541661254BX/0082192503542361324BX/0082192503543061338BX/0082192503544761346BX/0082192503545461354BX/00821925035461
- Model/UDI-DI
- Amount recalled
- 14,093 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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