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Thermogard HQ Surface Start-Up Kit

Zoll Circulation, Inc. · Model Surface Start-Up Kit · UDI-DI 00849111076074

NZE Prescription

510(k) clearances

Adverse events (1 deaths)

Recalls

Facilities

Description

The Surface Start-Up Kit is a tubing set that connects the Thermogard XP® console to a STx™ Vest or Thermogard™ Vest surface pad. The Surface Start-Up Kit is a closed-loop disposable that is composed of a pre-attached water reservoir, an extension tubing, a pump loop, a heat exchange coil and an air trap assembly. All of these items work with the console to supply cool water to the surface pad to regulate patient core temperature."

Recalls

Date	Firm	Reason
2011-10-21	Life Recovery Systems HD, LLC	ThermoSuit System Model TSP-50 Pump/Controller may have corrosion on the temperature circuit board which may result in incorrect patient temperature reading.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.