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U.S. Department of Health and Human Services

Class 2 Device Recall HALO360 Ablation Catheter

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 Class 2 Recall
HALO360 Ablation Catheter
see related information
Date Posted October 31, 2008
Recall Status1 Open
Recall Number Z-0192-2009
Recall Event ID 49515
Product Classification Electrosurgical, Cutting & Coagulation & Accessories - Product Code GEI
Product Hydrophobic HALO360 Filter that is packaged with HALO360+ Ablation Catheters Model numbers 32041-22, 32041-28, 32041-31 and 32041-34, and/or with HALO360 Sizing Balloon Model number 3441B.
Code Information Filter Lot number 78156 was packaged with Catheter Lot numbers: F1012714 , F1012715 , F1012716 , F1012718 , F1012721 , F1012723 , and F1012724, and/or with Sizing Balloon Lot number: F1012719.
Recalling Firm/
Manufacturer
Barrx Medical, Inc.
540 Oakmead Pkwy
Sunnyvale, California 94085-4022
Manufacturer Reason
for Recall
Some units may contain the wrong filter, which does not have the proper lock and may result in a leak.
FDA Determined
Cause 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Mix-Up of Materials/Components
Action The recall was initiated on September 18, 2008. All users and international distributors were informed by letter. The replacement filters were sent on 9/19/2008. Contact Barrx Medical, Inc. at 1-408-745-8000 for assistance.
Quantity in Commerce 650 units
Distribution Worldwide Distribution, including USA, Austria, Australia, Belgium, Canada, France, Netherlands, Switzerland, Sweden, and UK .
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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