Product Wiki · Recalls · Health Canada — Medical Devices

HEATER COOLER SYSTEM 3T (2016-06-21) — recall 55290

Health Canada — Medical Devices · Canada · 2016-07-19 · Type II

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Agency
Health Canada — Medical Devices
Recall identifier
55290
Date of alert
2016-07-19
Country / jurisdiction
Canada
Risk level
Type II
Risk type
recall
Product category
Medical devices
Product type
Medical devices
Notice status
Archived by the issuing authority — kept for reference
Reported risk: LivaNova has determined that certain oxygenators containing a heat-exchanger with a polymer membrane separating the blood compartment from the water compartment, when used with the cleaning an disinfection regimen described in the IFU for the heater cooler system 3T (IFU versions applicable since 2013), may result in diffusion of a small quantity of hydrogen peroxide from the water side to the blood side during a typical procedure, in a quantity that exceeds the allowable limits determined by LivaNova.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/heater-cooler-system-3t-2016-0

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