Terumo Cardiovascular Systems Corp recalls Custom Cardiovascular Procedure Kits; Over-Pressure Safety Valves. For use only in the extracorporeal circuit for the c…

Recall date

May 6, 2015

Source

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

Recall number

Z-1828-2015

FDA classification

Class II

Brand / firm

Terumo Cardiovascular Systems Corp

Sold / distributed

Distributed to the states of MO and FL.

Why it was recalled

The Overpressure Safety Valve is not cleared with an indication for use on the arterial side of the extracoporeal bypass circuit. It is intended for use only on the venous side. There is a remote possibility of minimal blood loss, fluid weeping, or dripping on the user.

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

What was recalled

Custom Cardiovascular Procedure Kits; Over-Pressure Safety Valves. For use only in the extracorporeal circuit for the cardiopulmonary bypass procedures for which the user designed it.