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U.S. Department of Health and Human Services

Class 2 Device Recall UroPass Ureteral Access Sheath

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  Class 2 Device Recall UroPass Ureteral Access Sheath see related information
Date Initiated by Firm May 19, 2023
Date Posted August 14, 2023
Recall Status1 Open3, Classified
Recall Number Z-2401-2023
Recall Event ID 92495
510(K)Number K051593  
Product Classification Accessories, catheter, g-u - Product Code KNY
Product UroPass Ureteral Access Sheaths, 5 pieces/box
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.
Recalling Firm/
Manufacturer		 Olympus Corporation of the Americas
3500 Corporate Pkwy
Center Valley PA 18034-8229
For Additional Information Contact
484-896-5000
Manufacturer Reason
for Recall		 Dilator tips may break in the package and in patients during surgical procedures.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action 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.
Quantity in Commerce 9520 eaches
Distribution Worldwide distribution - United States Nationwide and the countries of South Korea, Canada, Australia, Taiwan, Hong Kong, Japan, and Germany.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = KNY and Original Applicant = ACMI CORPORATION
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