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Recall Observatory FDA recall evidence

Device product

Hot Dog PATIENT WARMING, Underbody Warming Mattress + Return Electrode, 82 cm (32"), REF US501, to prevent or treat hypothermia

Z-1197-2025

December 16, 2024

Class II

Product summary

Firm
Augustine Temperature Management, LLC
Event
Event 96155
Status
Ongoing
Classification
Class II
Quantity
4 units
Official record key
device-enforcement:Z-1197-2025

Official wording

Reason: There is over-molding that stabilizes the connection between the cable and cable-entry on the mattress. It turns out that after about a year of use, the connector cable on the mattress can experience the same type of deflection that caused the intermittent connection with the cables connecting to the ESU.

Code information: UDI-DI UDI-DI 00855913001817, Serial Numbers: 1304292, 1304293, 1304296, 1304297

Distribution pattern: US Nationwide distribution in the states of TX, AL, NV; AU, NZ.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    There is over-molding that stabilizes the connection between the cable and cable-entry on the mattress. It turns out that after about a year of use, the connector cable on the mattress can experience the same type of deflection that caused the intermittent connection with the cables connecting to the ESU.