Recall Z-1748-2013— Boston Scientific Corporation

Class II FDA medical device recall by Boston Scientific Corporation, initiated 2013-05-28, terminated 2013-08-28. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: 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..

Recalling firm

Boston Scientific Corporation

Classification

Class II

Status

Terminated

Initiated

2013-05-28

Terminated

2013-08-28

Firm location

Marlborough, MA, United States

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