Recall Z-1198-2025 ยท DWJ System, Thermal Regulating
Augustine Temperature Management, LLC
Hot Dog PATIENT WARMING, Underbody Warming Mattress + Return Electrode, 127 cm (50"), REF US502, to prevent or treat hypothermia
| Date | Feb 20, 2025 (initiated Dec 16, 2024) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Device Design |
| Action | Augustine Temperature Management began notifying its consignees on 12/16/2024 via email and visit to exchange the affected product. |
| Quantity | 1 unit |
| Distribution | US Nationwide distribution in the states of TX, AL, NV; AU, NZ. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.