—#118510

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.

FDA product code: OOY — Bronchial Thermoplasty System
Device class: Class 3
Medical specialty: Unknown
PMA numbers: P080032
Affected lot / code info: Lot/batch Number: CM040212; Exp. Date: April 2014

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.

Root cause (FDA determination)

Error in labeling

Action the firm took

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 .

Recalling firm

Firm: Boston Scientific Corporation
Address: 100 Boston Scientific Way, Marlborough, Massachusetts 01752-1234

Distribution

Distribution pattern: Worldwide distribution: US (nationwide) including states of: CA, FL, IA, ID, MI, OK, TA and WA; and countries of: Canada and Thailand.

Timeline

Recall initiated: 2013-05-28
Posted by FDA: 2013-07-17
Terminated: 2013-08-28
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #118510. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.