Boston Scientific Recalls Alair Bronchial Thermoplasty Catheters Due to Labeling Error
Boston Scientific is recalling 35 units of Alair Bronchial Thermoplasty Catheters because the expiration date on the inner tray is incorrect.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is due to a documentation and packaging labeling error regarding the expiration date, which falls under the 'Low' severity criteria for cosmetic or documentation issues.
Plain-English summary
Boston Scientific Corporation is recalling 35 units of the Alair Bronchial Thermoplasty Catheter, part of the Alair Bronchial Thermoplasty System. The affected product is identified by Material Number M005ATS25010, Catalog Number ATS 2-5, and Lot Number CM040212.
The recall was initiated because the expiration date printed on the inner tray of the packaging is incorrect. The inner tray displays an expiration date of 2012-04, while the correct expiration date, as indicated on the outer box label, is 2014-04. The product is indicated for the treatment of severe persistent asthma in patients 18 years and older.
The affected units were distributed worldwide, including nationwide in the United States (specifically in CA, FL, IA, ID, MI, OK, TA, and WA) and in Canada and Thailand. Users should check their inventory for this specific lot number and contact Boston Scientific for instructions on how to return the product.
The recalled product
- 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…
- Manufacturer
- Boston Scientific Corporation
- Category
- Medical Device — Respiratory
- Hazard
- Affected units
- 35
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot/batch Number: CM040212
- Exp. Date: April 2014
Distribution
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