FDANovember 27, 2017device
Hemotherm¿ Dual Reservoir Cooler/Heater System Models 400CE and 400MR Product Usage: A dual reservoir, water re-circulating device that supplies temperature controlled water to a heat exchanger. The device, in conjunction with a heat exchanger, is used to warm or cool the blood that enters and ex...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Due to FDA's safety communication relating to nontuberculous mycobacteria (NTM) infections related to heater/cooler devices, an updated Instructions For Use includes a more robust cleaning & disinfection procedure.
What to do
FDA enforcement status: Terminated
Brands named
cincinnati sub zero productscincinnaticincinnati sub
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- CPSCYamazuki Recalls Youth All-Terrain Vehicles (ATVs) Due to Risk of Serious Injury or Death from Crash; Violate Mandatory Standard for ATVs2026-06-25
- CPSCResistance Bands Recalled Due to Serious Injury from Impact Hazard; Imported by HomeProGym2026-05-21
- FDAFarm Rich Pizza Cheese Crunchers2026-05-19
- FDADairy House Ingredient Systems Strawberry Dairy Powder 05#5072-50, 50 lb bags2026-05-18
- FDALegacy Tex Dressing Stabilizer Blend #7604-50, 50lb bags2026-05-18
- FDADairy House Ingredient Systems Vanilla Dairy Powder, 50 lb box2026-05-18
- FDAHydroMARK Breast Biopsy Site Marker, Model Number: 4010-02-15-T32026-04-24
- FDAPremier, Monsel's, Ferric Subsulfate Solution, 8 mL bottles, Rx only, Manufacturer: Premier Medical Products, 1710 Romano Drive, Plymouth Meeting, PA 19462, NDC 48783-112-08.2026-04-14
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