Reported Feb 21, 2018 · Terminated
Hemotherm¿ Dual Reservoir Cooler/Heater System Models 400CE and 400MR Product Usage: A dual reservoir, water…
Cincinnati Sub-Zero Products LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Cincinnati Sub-Zero Products LLC · 12011 Mosteller Rd · Cincinnati, OH · 45241-1528
Is this the product you have?
- Hemotherm¿ Dual Reservoir Cooler/Heater System
- Models 400CE and 400MR Product UsageA 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 exits a blood heat exchanger for adult, pediatric or infant patients
- Lot codes and dates
- none
- Amount recalled
- 1355 units
Where it was sold
- Nationwide
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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