The Recall Desk
ModerateFDA (Devices)·Z-0933-2014·Announced 2014-02-12

Stryker Recalls Gaymar Medi-Therm Devices Due to Missing Water Temperature Display

Stryker is recalling 1,002 Gaymar Medi-Therm devices because the water temperature display is blank in Auto mode, potentially preventing users from verifying water temperature.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, which typically indicates a situation where use of the product may cause temporary or medically reversible health consequences. The defect involves a missing display rather than a direct mechanical failure causing injury, fitting the Moderate category for a risk-of-harm product where injury has not yet been reported.

Plain-English summary

Stryker Medical Division of Stryker Corporation is recalling 1,002 units of the Gaymar Medi-Therm device. The recall is due to a defect where the water temperature display is blank while the unit is operating in Auto mode. In this mode, only the patient temperature and set point are displayed, leaving the water temperature field empty.

The Gaymar Medi-Therm device is used to regulate patient temperature by supplying temperature-controlled water to accessory blankets or body wraps. The device controls output water temperature by mixing hot and cold water using solenoid valves under microprocessor control. The affected units were distributed nationwide and worldwide.

Users who switch from Auto mode to Manual mode and back to Auto mode may observe the water temperature display. However, the source text does not specify if this workaround is recommended or if the display functions correctly in Manual mode. Consumers and healthcare facilities should check their device serial numbers against the list provided by the FDA and contact Stryker for instructions on repair or replacement.

The recalled product

Product
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
Affected units
1,002

Distribution

Distributed nationwide across the United States.