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Augustine Temperature Management, LLC FDA Recalls
13 recalls on file across devices, 0 of them Class I and 8 still open. This firm is not matched to a listed company.
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Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
|---|
| Hot Dog PATIENT WARMING, Underbody Warming Mattress + Return Electrode, 82 cm (32"), REF US501, to prevent or treat hypoClass IIDec 16, 2024There is over-molding that stabilizes the connection between |
| Hot Dog PATIENT WARMING, Underbody Warming Mattress + Return Electrode, 127 cm (50"), REF US502, to prevent or treat hypClass IIDec 16, 2024There is over-molding that stabilizes the connection between |
| Hot Dog PATIENT WARMING, Underbody Warming Mattress + Return Electrode, 89 cm (35"), REF US530, to prevent or treat hypoClass IIDec 16, 2024There is over-molding that stabilizes the connection between |
| Augustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Controller, Multiport, Models: 1) Model # WC7Class IIDec 4, 2024Instructions for use update on HotDog Temperature Management |
| Augustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Controller, Single Port, Models: 1) Model # WClass IIDec 4, 2024Instructions for use update on HotDog Temperature Management |
| Hillrom Temperature Management Controller, MP, Model # 2083516; used in conjunction with Warming Blankets and MattressesClass IIDec 4, 2024Instructions for use update on HotDog Temperature Management |
| Augustine Surgical Inc. HotDog Return Electrode accessory connector cables, Model A136 used in conjunction with WarmingClass IIFeb 15, 2024Users were experiencing the following error message (M-0B-12 |
| Augustine Surgical Inc. HotDog Return Electrode accessory connector cables, Model A138 used in conjunction with Warming Class IIFeb 15, 2024Users were experiencing the following error message (M-0B-12 |
| Augustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Controller, Single Port, Models: 1) Model # WClass IIMar 14, 2022HotDog Temperature Management Controllers Models WC71, WC77, |
| Augustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Controller, Single Port, Models: 1) Model # WClass IIMar 14, 2022HotDog Temperature Management Controllers Models WC71, WC77, |
| Hillrom Temperature Management Controller, MP, Model # 2083516; used in conjunction with Warming Blankets and MattressesClass IIMar 14, 2022HotDog Temperature Management Controllers Models WC71, WC77, |
| Augustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Controller, Single Port, Models: 1) WC77V; Class IIMar 14, 2022HotDog Temperature Management Controllers Models WC71, WC77, |
| Augustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Controller, Single Port, Models: 1) WC71V; Class IIMar 14, 2022HotDog Temperature Management Controllers Models WC71, WC77, |