Class 3 Device Recall

• Date Initiated by Firm: May 13, 2004
• Date Posted: March 23, 2005
• Recall Status: Terminated 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/ Manufacturer: Teleflex Medical, Inc.; 2450 Meadowbrook Pkwy; Duluth GA 30096-4635
• For Additional Information Contact: Ms Diane Luo; 919-361-4034
• Manufacturer Reason for Recall: Firm received complaints of leaking urine collection bags.
• FDA Determined Cause: Other
• 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