Device 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.
Z-1748-2013
Product summary
- Event
- Event 65303
- Status
- Terminated
- Classification
- Class II
- Quantity
- 35 units
- Official record key
device-enforcement:Z-1748-2013
Official wording
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.
Code information: Lot/batch Number: CM040212; Exp. Date: April 2014
Distribution pattern: Worldwide distribution: US (nationwide) including states of: CA, FL, IA, ID, MI, OK, TA and WA; and countries of: Canada and Thailand.
Derived failure modes
-
Unknown
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.