Reported Jul 24, 2013 · Terminated
Alair Bronchial Thermoplasty Catheter, Bronchial Thermoplasty System; Material Number: M005ATS25010, Catalog Number:…
Boston Scientific Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Boston Scientific Corporation · 100 Boston Scientific Way · Marlborough, MA · 01752-1234
Is this the product you have?
- Alair Bronchial Thermoplasty Catheter, Bronchial Thermoplasty System
- Material NumberM005ATS25010
- Catalog NumberATS 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
- Lot codes and dates
- Lot/batch NumberCM040212; Exp
- DateApril 2014
- Amount recalled
- 35 units
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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