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Health product recall

Alair Bronchial Thermoplasty System (2013-05-31)

Starting date:
May 31, 2013
Posting date:
December 17, 2013
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type III
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-37157

Recalled products

A. Alair Bronchial Thermoplasty System 

Reason

Boston Scientific has discovered an inconsistent "use by" expiration date on a single lot/batch of Alair bronchial thermoplasty catheters. The expiration date is listed in two locations on the packaging of the product,the outer box label and the inner tray label. The expiration date on the outer box label, 2014-04, is correct. However, the expiration date on the inner tray, 2012-04, is incorrect.

Affected products

A. Alair Bronchial Thermoplasty System

Lot or serial number
  • CM040212
Model or catalog number
  • ATS 2-5
Companies
Manufacturer

Boston Scientific Corporation

100 - 888 Ross Drive

Sunnyvale

94089

California

UNITED STATES