Home / Recalls / Olympus Corporation of the Americas / Z-2401-2023

Z-2401-2023 Class II Ongoing

Recalled by Olympus Corporation of the Americas — Center Valley, PA

Recall Details

Product Type
Devices
Report Date
August 23, 2023
Initiation Date
May 19, 2023
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
9520 eaches

Product Description

UroPass Ureteral Access Sheaths, 5 pieces/box

Reason for Recall

Dilator tips may break in the package and in patients during surgical procedures.

Distribution Pattern

Worldwide distribution - United States Nationwide and the countries of South Korea, Canada, Australia, Taiwan, Hong Kong, Japan, and Germany.

Code Information

Models: 61024BX, 61038BX, 61046BX, 61054BX, 61124BX, 61138BX, 61146BX, 61154BX, 61224BX, 61238BX, 61246BX, 61254BX, 61324BX, 61338BX, 61346BX, 61354BX Lots: All products manufactured in 2018 and 2019. Manufacturing date is printed on pouch label in YYYY-MM-DD format.

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