FDA-Device2014-01-08Class II
Terumo Cardiovascular Custom Cardiovascular Procedure Kits containing an Overpressure Safety Valve, LN130B, in the Arterial Recirculation Line
Terumo Cardiovascular Systems Corporation
Hazard
Over-Pressure Safety Valves not cleared with an indication for use on the arterial side of the extracorporeal bypass circuit.
Sold states
Nationwide Canada
Affected count
24,227.
Manufactured in
125 Blue Ball Rd, Elkton, MD, United States
Products
Terumo Cardiovascular Custom Cardiovascular Procedure Kits containing an Overpressure Safety Valve, LN130B, in the Arterial Recirculation Line
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0603-2014Don't want to check this manually?
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