Hot Dog PATIENT WARMING, Underbody Warming Mattress + Return Electrode, 82 cm (32"), REF US501, to prevent or treat hypothermia
This recall is currently active, issued February 20, 2025. It was issued by Augustine Temperature Management, Llc.
- Recall Initiated
- December 16, 2024
- Posted
- February 20, 2025
- Recall Number
- Z-1197-2025
- Quantity
- 4 units
- Firm Location
- Minnetonka, MN
- Official Source
- View on FDA website ↗
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.
Lot / Code Info
UDI-DI UDI-DI 00855913001817, Serial Numbers: 1304292, 1304293, 1304296, 1304297
Root Cause
Device Design
Action Taken
Augustine Temperature Management began notifying its consignees on 12/16/2024 via email and visit to exchange the affected product.