Drug recall
RigiflexTM 11 Single-Use Achalasia Balloon Dilator, Material Number (UPN) M00554510 Product Usage: The Boston…
FDA recall event 65347 · Class III · Boston Scientific Corporation
Key facts
| Event ID | 65347 |
|---|---|
| Recall numbers | Z-1671-2013 |
| Recalling firm | Boston Scientific Corporation |
| Product type | Devices |
| Products | RigiflexTM 11 Single-Use Achalasia Balloon Dilator, Material Number (UPN) M00554510 Product Usage: The Boston Scientific Corporation RigiflexTM II Single- Use Achalasia Balloon Dilator is indicated… |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Product labeled with incorrect expiration date. |
| Initiation date | May 28, 2013 |
| Report date | Jul 17, 2013 |
| Termination date | Feb 10, 2014 |
| 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: