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U.S. Department of Health and Human Services

Class 3 Device Recall MEDRX

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  Class 3 Device Recall MEDRX see related information
Date Initiated by Firm August 19, 2022
Date Posted November 11, 2022
Recall Status1 Terminated 3 on March 20, 2023
Recall Number Z-0202-2023
Recall Event ID 90926
510(K)Number K010607  
Product Classification System, irrigation, urological - Product Code LJH
Product MED-RX UROLOGICAL CYSTO/BLADDER IRRIGATION SET, REF 10-4001
Code Information UDI/DI: 00628725001050, Lot Numbers: 159603, exp 2026-12-01 and 166945, exp 2027-06-01
Recalling Firm/
Manufacturer		 Canadian Hospital Specialties
2760 Brighton Rd
Oakville Canada
Manufacturer Reason
for Recall		 Some of the labels of the kits for product code 10-4001 in the specified lots have an illegible barcode which prevents successful scanning of the package.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action The firm issued a MEDICAL DEVICE RECALL NOTICE to its consignees on 08/23/2022 by email. The notice explained the issue and requested the following: "TO IMPLEMENT THIS RECALL, PLEASE PERFORM THE FOLLOWING ACTIONS: 1.Examine your stock and determine if you have any affected product and lot. 2.Complete the attached Product Recall Response Form and send torecalls@chsltd.com. 3.Please report any affected units of the product to CHS for further instructions." For questions, contact: recalls @chsltd.com
Quantity in Commerce 9100 units
Distribution US
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = LJH and Original Applicant = BENLAN, INC.
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