Reported Feb 12, 2014 · Terminated
The Gaymar Medi-Therm device provides a means of regulating patient temperature by supplying temperature-controlled…
Stryker Medical Division of Stryker 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: Stryker Medical Division of Stryker Corporation · 3800 E Centre Ave · Portage, MI · 49002-5826
Is this the product you have?
- The Gaymar Medi-Therm device provides a means of regulating patient temperature by supplying temperature-controlled water through a connector hose to accessory Gaymar Hyper/Hypothermia blanket(s)/body wrap(s). The blanket/body wrap provides an interface for heating or cooling the patient. Accessory YSI 400 series patient probe interfaces between the Medi-Therm and patient to sense patient temperature, which is displayed on the device's control panel. The Medi-Therm device controls output water temperature by mixing hot and cold water using hot and cold solenoid valves under microprocessor control. The device includes a circulating pump, heater and refrigeration system. The Medi-Therm controller, connector hose, blanket/body wrap and patient probe comprise the Medi-Therm Hyper/Hypothermia System.
- Lot codes and dates
- Domestic Serial NumbersInternational Serial Numbers
943 of 943 codes
MTA7900C01023MTA7900E01043MTA7900F01021MTA7900F90020MTA7900G90007MTA7900B90022MTA7900B90023MTA7900D80022MTA7900B01006MTA7900B01009MTA7900B01012MTA7900H90007MTA7900H90008MTA7900A01019MTA7900A01020MTA7900A01024MTA7900D01028MTA7900F01002MTA7900H80009MTA7900H80021MTA7900G90016MTA7900H90006MTA7900K90056MTA7900K90061MTA7900K90063MTA7900L90003MTA7900L90006MTA7900L90020MTA7900H80057MTA7900E01016MTA7900I90006MTA7900I90038MTA7900B90020MTA7900E80014MTA7900E80020MTA7900E80027MTA7900I90023MTA7900I90027MTA7900E90031MTA7900I90031MTA7900I90041MTA7900H90004MTA7900B80004MTA7900A80028MTA7900E80054MTA7900E01042MTA7900D80001MTA7900C01012MTA7900J90018MTA7900A01028MTA7900E80046MTA7900J70023MTA7900J70024MTA7900J70025MTA7900J70026MTA7900J70027MTA7900J70031MTA7900J70032MTA7900E80011MTA7900E80035
MTA7900E01003MTA7900H90003MTA7900A90014MTA7900A90015MTA7900I90047MTA7900I90049MTA7900I90050MTA7900I90051MTA7900I90052MTA7900J90001MTA7900J90002MTA7900J90003MTA7900J90004MTA7900J90006MTA7900J90008MTA7900J90009MTA7900J90010MTA7900A01022MTA7900E01031MTA7900E80003MTA7900E80019MTA7900F01047MTA7900H80025MTA7900H80041MTA7900H80045MTA7900I80004MTA7900I80007MTA7900I80008MTA7900L70006MTA7900L90019MTA7900F01043
- Domestic Serial Numbers
- Amount recalled
- 1002 units
Where it was sold
- Nationwide
Why it was recalled
Stryker Medical has identified that on some units of the MTA7900, there is a lack of a water temperature display while the unit is in Auto mode. While in Auto mode, only the patient temperature is displayed along with the set point. The water display will be blank during Auto mode. If the user wants to see the water temperature displayed and switches out of Auto mode to Manual mode, then back to
This product could cause temporary or reversible health problems — stop using it.
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