Drug recall
Alair Bronchial Thermoplasty Catheter, Bronchial Thermoplasty System; Material Number: M005ATS25010, Catalog…
FDA recall event 65303 · Class II · Boston Scientific Corporation
Key facts
| Event ID | 65303 |
|---|---|
| Recall numbers | Z-1748-2013 |
| Recalling firm | Boston Scientific Corporation |
| Product type | Devices |
| Products | Alair Bronchial Thermoplasty Catheter, Bronchial Thermoplasty System; Material Number: M005ATS25010, Catalog Number: ATS 2-5. Product is manufactured and distributed by Boston Scientific Corporation… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | 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… |
| Initiation date | May 28, 2013 |
| Report date | Jul 24, 2013 |
| Termination date | Aug 28, 2013 |
| City | Marlborough |
| State | MA |
| Country | United States |
| FEI number | 3005099803 |
At a glance
- 1–9 Products in this recall
- None FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: