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U.S. Department of Health and Human Services

Class 2 Device Recall Alair Bronchial Thermoplasty Catheter

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 Class 2 Recall
Alair Bronchial Thermoplasty Catheter
see related information
Date Posted July 17, 2013
Recall Status1 Terminated on August 28, 2013
Recall Number Z-1748-2013
Recall Event ID 65303
Premarket Approval
PMA Number
P080032
Product Classification Bronchial Thermoplasty System - Product Code OOY
Product Alair Bronchial Thermoplasty Catheter, Bronchial Thermoplasty System; Material Number: M005ATS25010, Catalog Number: ATS 2-5. Product is manufactured and distributed by Boston Scientific Corporation (BSC), Sunnyvale, CA The Alair Bronchial Thermoplasty System (including the Alair Bronchial Thermoplasty Catheter) is indicated for the treatment of severe persistent asthma in patients 18 years and older whose asthma is not well controlled with inhaled corticosteroids and long acting beta agonists.
Code Information Lot/batch Number: CM040212; Exp. Date: April 2014
Recalling Firm/
Manufacturer
Boston Scientific Corporation
100 Boston Scientific Way
Marlborough, Massachusetts 01752-1234
Manufacturer Reason
for Recall
Boston Scientific has discovered an inconsistent "Use By" expiration date on a single lot/batch of Alair Bronchial Thermoplasty Catheters. The expiration date indicated on the inner tray, 2012-04, is incorrect. The correct expiration date is 2014-04 as indicated on the outer box label.
FDA Determined
Cause 2
PRODUCTION CONTROLS: Error in Labeling
Action The firm, Boston Scientific, sent a letter dated May 28, 2013, via express mail to all its direct consignees. The letter described the product, problem and actions to be taken. The customers were informed that you can continue to use the device until the expiration date on the outer box lablel, 2014-04; No product is being recalled and the you are not required to return product to Boston Scientific. The customers were instructed to read the enclosed information carefully and post the information in a conspicuous location near the affected product and/or take such other steps, consistent with your internal policies and procedures, to ensure that the information is easily accessible to all users of this device; and to complete and return the Customer Acknowledgment Form even if you no longer have any units from the affected lot/batch via email: MapleGroveFieldAc@bsci.com or Fax to: Field Action Center - 1866-213-1806. If you have any questions, call 763-494-1133 or email: MapleGroveFieldAc@bsci.com .
Quantity in Commerce 35 units
Distribution Worldwide distribution: US (nationwide) including states of: CA, FL, IA, ID, MI, OK, TA and WA; and countries of: Canada and Thailand.
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.
PMA Database PMAs with Product Code = OOY and Applicant = ASTHMATX, INC.
PMAs with Product Code = OOY and Applicant = BOSTON SCIENTIFIC CORP.
PMAs with Product Code = OOY and Applicant = BOSTON SCIENTIFIC CORPORATION (BSC)
PMAs with Product Code = OOY and Applicant = BOSTONSCIENTIFIC
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