Reported Feb 25, 2015 · Terminated
Terumo HX2 Temperature Management System provides temperature control of two independent water circuits that directly…
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 · 6200 Jackson Rd · Ann Arbor, MI · 48103-9586
Is this the product you have?
- Terumo HX2 Temperature Management System provides temperature control of two independent water circuits that directly controls the temperature of patient blood and cardioplegia solution during cardiovascular surgery.
- Lot codes and dates
HX2 Temperature Management System120V Catalog # 809810
- serial numbers00016, 0001 1116 HX2 Temperature Management System, 100V Catalog # 812231
- serial numbers
00011002PT0003PT0004 HX2 Temperature Management System240V Catalog # 812240
- serial numbers
00010002 HX2 Temperature Management SystemTrial Kit Catalog # 809810TK
- serial numbers1001 1042
- Amount recalled
- 103 units
Where it was sold
Why it was recalled
Malfunctioning mixing valve and loss of cooling and/or heating capability. System goes to standby mode and shows error messages EOd (invalid mix valve measured range of motion) or EOE (valve unable to move or complete a motion). Mixing valves need to be replaced at regular intervals.
This product could cause temporary or reversible health problems — stop using it.
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