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Terumo Cardiovascular Systems Corporation recalls Terumo Cardiovascular Custom Cardiovascular Procedure Kits containing an Overpressure Safety Valve, LN130B, in the Arter
Recalled January 8, 2014 · FDA recall Z-0603-2014 · Terumo Cardiovascular Systems
Hazard
Over-Pressure Safety Valves not cleared with an indication for use on the arterial side of the extracorporeal bypass circuit. · FDA Class II
Units
24,227.
Sold at
Nationwide Canada
Description
Over-Pressure Safety Valves not cleared with an indication for use on the arterial side of the extracorporeal bypass circuit.
Product
Terumo Cardiovascular Custom Cardiovascular Procedure Kits containing an Overpressure Safety Valve, LN130B, in the Arterial Recirculation Line
Manufacturer(s)
Terumo Cardiovascular Systems Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →