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Terumo Cardiovascular Systems Corp recalls Custom Cardiovascular Procedure Kits; Over-Pressure Safety Valves. For use only in the extracorporeal circuit for the
Recalled July 1, 2015 · FDA recall Z-1828-2015 · Terumo Cardiovascular Systems
Hazard
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. · FDA Class II
Units
163 devices
Sold at
Distributed to the states of MO and FL.
Description
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.
Product
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.
Manufacturer(s)
Terumo Cardiovascular Systems Corp
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →