Z-1198-2025 Class II Ongoing
FDA device recall Z-1198-2025 was initiated by Augustine Temperature Management, LLC on December 16, 2024 and is designated Class II. 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 recall status is ongoing. Affected quantity: 1 unit.
Recall Details
- Product Type
- Devices
- Report Date
- February 26, 2025
- Initiation Date
- December 16, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1 unit
Product Description
Hot Dog PATIENT WARMING, Underbody Warming Mattress + Return Electrode, 127 cm (50"), REF US502, 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 Pattern
US Nationwide distribution in the states of TX, AL, NV; AU, NZ.
Code Information
UDI-DI UDI-DI 00855913001824, Serial Numbers: 1304283