Augustine Temperature Management, LLC

FDA Regulatory Profile

Summary

Total Recalls
13
510(k) Clearances
5
Inspections
5
Compliance Actions
2

Recent Recalls

NumberClassProductDate
Z-1197-2025Class IIHot Dog PATIENT WARMING, Underbody Warming Mattress + Return Electrode, 82 cm (32"), REF US501, to pDecember 16, 2024
Z-1199-2025Class IIHot Dog PATIENT WARMING, Underbody Warming Mattress + Return Electrode, 89 cm (35"), REF US530, to pDecember 16, 2024
Z-1198-2025Class IIHot Dog PATIENT WARMING, Underbody Warming Mattress + Return Electrode, 127 cm (50"), REF US502, to December 16, 2024
Z-0700-2025Class IIAugustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Controller, Single Port, ModDecember 4, 2024
Z-0701-2025Class IIAugustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Controller, Multiport, ModelDecember 4, 2024
Z-0702-2025Class IIHillrom Temperature Management Controller, MP, Model # 2083516; used in conjunction with Warming BlaDecember 4, 2024
Z-1172-2025Class IIAugustine Surgical Inc. HotDog Return Electrode accessory connector cables, Model A138 used in conjuFebruary 15, 2024
Z-1171-2025Class IIAugustine Surgical Inc. HotDog Return Electrode accessory connector cables, Model A136 used in conjFebruary 15, 2024
Z-0841-2025Class IIHillrom Temperature Management Controller, MP, Model # 2083516; used in conjunction with Warming BlaMarch 14, 2022
Z-0842-2025Class IIAugustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Controller, Single Port, ModMarch 14, 2022
Z-0843-2025Class IIAugustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Controller, Single Port, ModMarch 14, 2022
Z-0839-2025Class IIAugustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Controller, Single Port, ModMarch 14, 2022
Z-0840-2025Class IIAugustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Controller, Single Port, ModMarch 14, 2022

Recent 510(k) Clearances

K-NumberDeviceDate
K232627HotDog Warming Mattress + Return ElectrodeApril 18, 2024
K230866HotDog Warming Mattress + Return ElectrodeJune 29, 2023
K220941HotDog Temperature Management SystemSeptember 23, 2022
K210727HotDog Warming Mattress + Return ElectrodeFebruary 1, 2022
K201779HotDog Temperature Management ControllerSeptember 11, 2020