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, 61146

Hazard

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.

Details from the source

Reason for recall: 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. Distribution: Worldwide distribution - US Nationwide and the countries of Australia, Canada, China, Germany, Hong Kong, Japan, Republic of South Korea, Singapore. Quantity: 14,093 units Lot/code info: Model/UDI-DI: 61024BX/00821925035317, 61038BX/00821925035324, 61046BX/00821925035331, 61054BX/00821925035348, 61124BX/00821925035355, 61138BX/00821925035362, 61146BX/00821925035379, 61154BX/00821925035386, 61224BX/00821925035393, 61238BX/00821925035409, 61246BX/00821925035416, 61254BX/00821925035423, 61324BX/00821925035430, 61338BX/00821925035447, 61346BX/00821925035454, 61354BX/00821925035461.

UPC codes

00821925035317, 00821925035324, 00821925035331, 00821925035348, 00821925035355, 00821925035362, 00821925035379, 00821925035386, 00821925035393, 00821925035409, 00821925035416, 00821925035423, 00821925035430, 00821925035447, 00821925035454, 00821925035461

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.