FDA recall Z-1197-2025

Augustine Temperature Management, LLC · Class II · device

Product

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

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.

Key facts

Status
Ongoing
Initiation date
2024-12-16
Report date
2025-02-26
Voluntary/Mandated
Voluntary: Firm initiated
Location
Minnetonka, MN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1197-2025