Cincinnati Sub-Zero recalls Hemotherm 400CE and 400MR models due to potential nontuberculous mycobacteria (NTM) infections from improper cleaning. Updated instructions require enhanced disinfection procedures to reduce infection risk.
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.
Cincinnati Sub-Zero is recalling Hemotherm Dual Reservoir Cooler/Heater Systems models 400CE and 400MR because they could pose a risk of nontuberculous mycobacteria (NTM) infections if not cleaned properly. This is a serious health concern for patients using blood temperature control systems.
The device can harbor nontuberculous mycobacteria (NTM) if not cleaned and disinfected correctly, which may lead to infections in patients with compromised immune systems. The FDA issued a safety update requiring more rigorous cleaning procedures to reduce this risk.
Patients using the Hemotherm systems for blood temperature control during medical procedures are most at risk. The recall affects specific models sold for adult, pediatric, and infant patients.
Check for the model numbers 400CE or 400MR on the Hemotherm Dual Reservoir Cooler/Heater System. These models were sold for use with blood heat exchangers in medical settings.
Follow the updated Instructions For Use for enhanced cleaning and disinfection to reduce NTM infection risk.
The FDA identified a potential risk of nontuberculous mycobacteria (NTM) infections if the device is not cleaned properly. Updated instructions require more rigorous cleaning procedures.
Hemotherm Dual Reservoir Cooler/Heater Systems models 400CE and 400MR.
No, but you must follow the updated cleaning instructions to reduce infection risk.
We’ve drafted a message you can send Cincinnati Sub-Zero to request your refund or repair — edit it as you like.
Subject: Recall Z-0629-2018 — Cincinnati Sub-Zero Cincinnati Sub-Zero Hello, I own a Cincinnati Sub-Zero that is covered by recall Z-0629-2018 from Cincinnati Sub-Zero. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
