Terumo Medical Corporation recalls PINNACLE¿ Introducer Sheath PINNACLE PRECISION ACCESS SYSTEM¿ Sheath PINNACLE¿ TIF TIP" Introducer Sheath PINNACLE¿ R/O…

Recall date

March 16, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2738-2016

FDA classification

Class II

Brand / firm

Terumo Medical Corporation

Sold / distributed

Nationwide Distribution

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

PINNACLE¿ Introducer Sheath PINNACLE PRECISION ACCESS SYSTEM¿ Sheath PINNACLE¿ TIF TIP" Introducer Sheath PINNACLE¿ R/O II Radiopaque Marker Introducer Sheath