Hot Dog PATIENT WARMING recalled over mold contamination
- Recall date
- December 16, 2024
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- Augustine Temperature Management, LLC recalls Hot Dog PATIENT WARMING, Underbody Warming Mattress + Return Electrode, 127 cm (50"), REF US502, to prevent or treat hy…
- Recall number
- Z-1198-2025
- FDA classification
- Class II
- Brand / firm
- Augustine Temperature Management, LLC
- Sold / distributed
- US Nationwide distribution in the states of TX, AL, NV; AU, NZ.
Why it was recalled
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.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Hot Dog PATIENT WARMING, Underbody Warming Mattress + Return Electrode, 127 cm (50"), REF US502, to prevent or treat hypothermia
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