Drug recall
PINNACLE¿ Introducer Sheath PINNACLE PRECISION ACCESS SYSTEM¿ Sheath PINNACLE¿ TIF TIP" Introducer Sheath…
FDA recall event 73833 · Class II · Terumo Medical Corporation
Key facts
| Event ID | 73833 |
|---|---|
| Recall numbers | Z-2738-2016 |
| Recalling firm | Terumo Medical Corporation |
| Product type | Devices |
| Products | PINNACLE¿ Introducer Sheath PINNACLE PRECISION ACCESS SYSTEM¿ Sheath PINNACLE¿ TIF TIP" Introducer Sheath PINNACLE¿ R/O II Radiopaque Marker Introducer Sheath |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Terumo Medical is initiating this recall due to complaints of valve leakage that have been related to a manufacturing issue. If affected introducer sheaths are used, there is possible risk of… |
| Initiation date | Mar 16, 2016 |
| Report date | Sep 14, 2016 |
| Termination date | Jan 27, 2017 |
| City | Elkton |
| State | MD |
| Country | United States |
| FEI number | 1118880 |
At a glance
- 1–9 Products in this recall
- 10–99 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: