Drug recall
Advanix Pancreatic Stent, Straight Leading Barb, 10F x 6cm UPN: M00536640
FDA recall event 84150 · Class II · Boston Scientific Corporation
Key facts
| Event ID | 84150 |
|---|---|
| Recall numbers | Z-0548-2020, Z-0549-2020, Z-0550-2020, Z-0551-2020, Z-0552-2020, Z-0553-2020, Z-0554-2020, Z-0555-2020, Z-0556-2020, Z-0557-2020, Z-0558-2020, Z-0559-2020 and 1 more |
| Recalling firm | Boston Scientific Corporation |
| Product type | Devices |
| Products | Advanix Pancreatic Stent, Straight Leading Barb, 10F x 6cm UPN: M00536640, Boston Advanix Pancreatic Stent, Straight Leading Barb, 10F x 4cm UPN: M00536620, Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 10cm UPN: M005336680, Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 11cm UPN: M005336690, Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 12cm UPN: M00536700 and 8 more |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Product manufactured between September 29, 2017 and September 12, 2019 have been labeled with a 36-month shelf life rather than the approved 18-month shelf life |
| Initiation date | Oct 21, 2019 |
| Report date | Dec 4, 2019 |
| Termination date | Dec 20, 2023 |
| City | Marlborough |
| State | MA |
| Country | United States |
| FEI number | 3005099803 |
At a glance
- 10–99 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: