Reported Jul 1, 2015 · Terminated
Custom Cardiovascular Procedure Kits; Over-Pressure Safety Valves. For use only in the extracorporeal circuit for the…
Terumo Cardiovascular Systems Corp.
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 Corp · 28 Howe St · Ashland, MA · 01721-1305
Is this the product you have?
- 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.
- Lot codes and dates
- Part Number66086-01:
- Lot NumbersRG09
- RM20 and Part Number70700-03:
- Lot Numbers
QL09RH07RL15QG17RD03
- Amount recalled
- 163 devices
Where it was sold
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.
This product could cause temporary or reversible health problems — stop using it.
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