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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 Sheathsee related information
Date Initiated by FirmMay 19, 2023
Date PostedAugust 14, 2023
Recall Status1 Open3, Classified
Recall NumberZ-2401-2023
Recall Event ID 92495
510(K)NumberK051593 
Product Classification Accessories, catheter, g-u - Product Code KNY
ProductUroPass 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.
FEI Number 2429304
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
ActionA 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 Commerce9520 eaches
DistributionWorldwide distribution - United States Nationwide and the countries of South Korea, Canada, Australia, Taiwan, Hong Kong, Japan, and Germany.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = KNY
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