Hot Dog PATIENT WARMING, Underbody Warming Mattress + Return Electrode, 127 cm (50"), REF US502, to prevent or treat hyp
FDA device recall Z-1198-2025 · posted 2025-02-20 · Open, Classified
Recall details
- Recalling firm
- Augustine Temperature Management, LLC
- 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.
- Action taken
- Augustine Temperature Management began notifying its consignees on 12/16/2024 via email and visit to exchange the affected product.
- Root cause
- Device Design
- Status
- Open, Classified
- Product code
- DWJ
- Quantity affected
- 1 unit
- Distribution
- US Nationwide distribution in the states of TX, AL, NV; AU, NZ.
- Date initiated
- 2024-12-16
- Date posted
- 2025-02-20
- Location
- Minnetonka, MN
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