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U.S. Department of Health and Human Services

Class 3 Device Recall

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  Class 3 Device Recall see related information
Date Initiated by Firm May 13, 2004
Date Posted March 23, 2005
Recall Status1 Terminated 3 on August 31, 2009
Recall Number Z-0647-05
Recall Event ID 31009
510(K)Number k871387  
Product Classification Collector, Urine, (And Accessories) For Indwelling Catheter - Product Code KNX
Product Latex-Free REF B1000, Belly Bag Urine Collection Bag with Hip Belt, ***1000 ml Lot***Sterile EO***Manufactured and Distributed by***Rusch Inc. 245 Meadowbrook Parkway, Duluth, GA 30096***Quantity 1
Code Information Lots 121870, 121871, 121872, 122515, 122517, 122518, 123273, 123274, 123275, 124066, 124333 and 124334.
Recalling Firm/
Teleflex Medical, Inc.
2450 Meadowbrook Pkwy
Duluth GA 30096-4635
For Additional Information Contact Ms Diane Luo
Manufacturer Reason
for Recall
Firm received complaints of leaking urine collection bags.
FDA Determined
Cause 2
Action Consignees were notified by letter on 5/13/2004. A follow up letter was sent on 11/22/2004.
Quantity in Commerce 6029 bags
Distribution Nationwide, Australia, Japan and the UK
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 = KNX and Original Applicant = ADVANCED CLINICAL PRODUCTS, INC.