Drug recall
Encore(TM) 26 Inflation Device, REF Catalog Nos.: (a) H74904526011, (b) M001151050, (c) M00566670, (d)…
FDA recall event 77820 · Class II · Boston Scientific Corporation
Key facts
| Event ID | 77820 |
|---|---|
| Recall numbers | Z-3043-2017 |
| Recalling firm | Boston Scientific Corporation |
| Product type | Devices |
| Products | Encore(TM) 26 Inflation Device, REF Catalog Nos.: (a) H74904526011, (b) M001151050, (c) M00566670, (d) M0067101140 |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Boston Scientific (BSC) has received complaints for cracked trays on the Encore device. |
| Initiation date | Jun 15, 2017 |
| Report date | Aug 23, 2017 |
| Termination date | Jul 22, 2020 |
| 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: