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U.S. Department of Health and Human Services

Enforcement Report - Week of July 24, 2013

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Product Detail

Product Description 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.
Recall Number Z-1748-2013
Classification Class II
Code Info Lot/batch Number: CM040212; Exp. Date: April 2014
Product Distributed Qty 35 units
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.

Event Detail

Event Id 65303
Product Type Devices
Status Ongoing
Recalling Firm Boston Scientific Corporation
City Marlborough
State MA
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-05-28
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Worldwide distribution: US (nationwide) including states of: CA, FL, IA, ID, MI, OK, TA and WA; and countries of: Canada and Thailand.