WebCincinnati Sub-Zero Products Inc, 12011 Mosteller Rd, Cincinnati OH 45241-1528 Manufacturer Parent Company (2024) Gentherm, Inc. Source USFDA 14 Events ... Hemotherm 48¿C Dual Reservoir Heater/Cooler System, Model Number: 400 and Model Number: 400MR. The 48 o ( Degree) C Hemotherm Dual Reservoir Heater/Cooler I … WebAug 1, 2024 · Background: Disseminated nontuberculous mycobacterium infections have occurred following surgical procedures involving extracorporeal circulation; contaminated water from heater-cooler...
510(k) Premarket Notification - Food and Drug Administration
WebNov 12, 2015 · Cincinnati Sub-Zero (CSZ) has received no reported incidents associated with NTM contamination or infection involving CSZ’s cooler-heater devices. However, … WebThe FDA has warned that bacterial infections have been linked to heater cooler units used throughout the country. The Mycobacterium chimaera is insidious, multiplying and spreading slowly over months and even years. ... Cincinnati Sub-Zero 333W and Hemotherm; Terumo HX2; Medical Device Reports (MDRs) are submitted to the FDA when a device is ... banktarif tg 7
Cincinnati Subzero Heater / Cooler Parts and Accessories - OEM …
WebOPERATION MANUAL MODEL 400CE DUAL RESERVOIR COOLER/HEATER. Cincinnati Sub-Zero Products, LLC. 12011 Mosteller Road Cincinnati, Ohio 45241, U.S.A. www.cszmedical.com ... i.e. skin irritation/rash or sepsis and infection may result. Upon receipt of the HEMOTHERM, the unit should be disinfected per the WATER SYSTEM … WebCDC has warned hospitals and patients about the potential risk of Nontuberculous Mycobacteria (NTM) infections from certain heater-cooler devices used during open heart (open-chest) surgery. Patients who have … WebJan 6, 2024 · Patients suspected of an infection associated with heater-cooler devices or exposed to a contaminated heater-cooler device should be notified and evaluated. … banktel training