Augustine Temperature Management, LLC: Hot Dog PATIENT WARMING, Underbody Warming Mattress + Return Electrode, 89 cm (35"), REF US530, to prevent or treat hypothermia

Hazard

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.

Details from the source

Reason for recall: 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. Distribution: US Nationwide distribution in the states of TX, AL, NV; AU, NZ. Quantity: 3 units Lot/code info: UDI-DI UDI-DI 00855913001848, Serial Numbers: 1304384, 1304619, 1304620

UPC codes

00855913001848

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.