FDADecember 16, 2024device
Hot Dog PATIENT WARMING, Underbody Warming Mattress + Return Electrode, 127 cm (50"), REF US502, to prevent or treat hypothermia
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
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.
What to do
FDA enforcement status: Ongoing
Brands named
augustine temperature managementaugustineaugustine temperature
UPCs
00855913001824
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDANeuroquell & Neuroquell Plus, .22 fl. Oz (6.6mL),Mfg. For/Dist. By Claire Ellen Products, P.O. Box 901 Westboro, MA 01581 USA, NDC 66233712-012025-08-27
- FDADubai emek SPREAD PISTACHIO CACAO CREAM WITH KADAYIF NET WT. 9.7oz UPC 8 69652 10130 1 Manufacturer: Emek Dogal Saglik Urunlerilkl. Gida Turkey2025-07-14
- FDAHot Dog PATIENT WARMING, Underbody Warming Mattress + Return Electrode, 89 cm (35"), REF US530, to prevent or treat hypothermia2024-12-16
- FDAHot Dog PATIENT WARMING, Underbody Warming Mattress + Return Electrode, 82 cm (32"), REF US501, to prevent or treat hypothermia2024-12-16
- FDAHillrom Temperature Management Controller, MP, Model # 2083516; used in conjunction with Warming Blankets and Mattresses.2024-12-04
- FDAAugustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Controller, Multiport, Models: 1) Model # WC77, 2) Model # WC77D (Demo), 3) Model # WC77R (Refurbished); used in conjunction with Warming Blankets and Mattresses.2024-12-04
- FDAAugustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Controller, Single Port, Models: 1) Model # WC71, 2) Model # WC71R (refurbished); used in conjunction with Warming Blankets and Mattresses.2024-12-04
- FDAAugustine Surgical Inc. HotDog Return Electrode accessory connector cables, Model A138 used in conjunction with Warming Blankets and Mattresses.2024-02-15
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