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Terumo Medical Corporation recalls PINNACLE¿ Introducer Sheath PINNACLE PRECISION ACCESS SYSTEM¿ Sheath PINNACLE¿ TIF TIP" Introducer Sheath PINNACLE¿ R
Recalled September 14, 2016 · FDA recall Z-2738-2016 · Terumo Medical
Hazard
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 incremental blood loss through the valve. · FDA Class II
Units
1,370,995 eaches have been distributed to the field
Sold at
Nationwide Distribution
Description
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 incremental blood loss through the valve.
Product
PINNACLE¿ Introducer Sheath PINNACLE PRECISION ACCESS SYSTEM¿ Sheath PINNACLE¿ TIF TIP" Introducer Sheath PINNACLE¿ R/O II Radiopaque Marker Introducer Sheath
Manufacturer(s)
Terumo Medical Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →