Reported Jan 8, 2014 · Terminated
Terumo Cardiovascular Custom Cardiovascular Procedure Kits containing an Overpressure Safety Valve, LN130B, in the…
Terumo Cardiovascular Systems Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Terumo Cardiovascular Systems Corporation · 125 Blue Ball Rd · Elkton, MD · 21921-5315
Is this the product you have?
- Terumo Cardiovascular Custom Cardiovascular Procedure Kits containing an Overpressure Safety Valve, LN130B, in the Arterial Recirculation Line
- Amount recalled
- 24,227.
Where it was sold
- Nationwide
Why it was recalled
Over-Pressure Safety Valves not cleared with an indication for use on the arterial side of the extracorporeal bypass circuit.
This product could cause temporary or reversible health problems — stop using it.
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