Drug recall
Boston Scientific Wallstent Endoprosthesis Tracheobronchial Self-Expanding Stent, 22MM X 45MM | 75CM L…
FDA recall event 80317 · Class II · SPS Sterilization, Inc
Key facts
| Event ID | 80317 |
|---|---|
| Recall numbers | Z-3027-2018, Z-3028-2018, Z-3029-2018, Z-3030-2018, Z-3031-2018, Z-3032-2018, Z-3033-2018, Z-3034-2018, Z-3035-2018, Z-3036-2018, Z-3037-2018, Z-3038-2018 and 3 more |
| Recalling firm | SPS Sterilization, Inc |
| Product type | Devices |
| Products | Boston Scientific Wallstent Endoprosthesis Tracheobronchial Self-Expanding Stent, 22MM X 45MM | 75CM L, resterilized., Boston Scientific Wallstent Endoprosthesis Tracheobronchial Self-Expanding Stent, 24MM X 70MM | 75CM L, resterilized., Boston Scientific Wallstent Endoprosthesis Tracheobronchial Transhepatic Biliary Self-Expanding Stent, 12MM X 90MM | 75CM L, resterilized., Boston Scientific Wallstent Enteral Endoprosthesis Colonic/Duodenal Stent, 22MM X 90MM, resterilized., Boston Scientific Wallstent RP Endoprosthesis Tracheobronchial Self-Expanding Stent, 10MM X 94MM | 135CM, resterilized. and 10 more |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | The expiration date on the device labeling exceeds its actual validated shelf life because the sterilization process used does not have adequate support for the extended shelf life. |
| Initiation date | Mar 7, 2018 |
| Report date | Sep 19, 2018 |
| Termination date | Nov 27, 2018 |
| City | Nixa |
| State | MO |
| Country | United States |
| FEI number | 3005057969 |
At a glance
- 10–99 Products in this recall
- 1–9 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: