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U.S. Department of Health and Human Services

Class 2 Device Recall HALO90 ULTRA Ablation Catheter Model 909200

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 Class 2 Recall
HALO90 ULTRA Ablation Catheter Model 909200
see related information
Date Posted July 06, 2011
Recall Status1 Terminated on September 07, 2011
Recall Number Z-2745-2011
Recall Event ID 58908
Premarket Notification
510(K) Number
K101111 
Product Classification Electrosurgical, Cutting & Coagulation & Accessories - Product Code GEI
Product HALO Ultra Ablation Catheter: Rx only; for use only with the Halo Flex Energy generator and accessories; Manufactured in the USA at B®RRX Medical, 540 Oakmead Parkway, Sunnyvale, CA 94085. Product Usage: Indicated for use in the coagulation of bleeding and nod-bleeding sites in the gastrointestinal tract including but not limited to the esophagus.
Code Information Model number: 90-9200: Serial numbers: F1013145; Exp 4/30/2013; F1013152, Exp 4/30/2013; F1013176, Exp 5/31/2013; F1013184, Exp 6/30/2013; F1013214, Exp 7/31/2013; F1013228, Exp 7/31/2013; F1013246, Exp 8/31/2013; F1013264, Exp 9/30/2013; F1013312, Exp 12/31/2013; F1013356, Exp 2/28/2014; F1013365. Ex0 2/28/2014; F1013370, Exp 3/31/2014; F1013377, Exp 3/31/2014.
Recalling Firm/
Manufacturer
Barrx Medical, Inc.
540 Oakmead Pkwy
Sunnyvale, California 94085-4022
For Additional Information Contact Greg Barrett
408-328-7308
Manufacturer Reason
for Recall
Complaints of malfunction of the HALO ULTRA Ablation Catheter related to the device pivot mechanism's inability to return the electrode cap to a flat neutral position.
FDA Determined
Cause 2
DESIGN: Component Design/Selection
Action BARRX Medical, Inc. sent a "PRODUCT RECALL NOTIFICATION" letter dated May 25, 2011 via Federal Express to all of their customers. The letter described the product, problem and actions to be taken. The customers were instructed to discontinue use of the recalled product. B®RRX Medical Territory Managers will be in contact with each facility and arrange for pick up of the recalled product. The "Steps for Voluntary Recall" form that is enclosed with each letter provides customers with complete instructions on segregating the product, completing the Tracking/Verification Form, obtaining Returned Good Authorization (RGA) number and preparing product for pick up. Customers are to complete and return the Tracking/Verification Form by fax to 408-738-1741 which should include amount of product on hand, contact name and hospital/distributor information. Questions should be directed to B®RRX Medical Customer Service at 888-662-2779.
Quantity in Commerce 936 devices
Distribution Worldwide Distribution -- USA (nationwide) and the countries of the United Kingdom and China
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.
510(K) Database 510(K)s with Product Code = GEI and Original Applicant = BARRX MEDICAL INC
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