HEATER COOLER SYSTEM 3T (2016-06-21)

Starting date:
June 21, 2016
Posting date:
July 19, 2016
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type II
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Hospitals, Healthcare Professionals
Identification number:
RA-59390

Affected products

A. HEATER COOLER SYSTEM 3T

Reason

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.

Affected products

A. HEATER COOLER SYSTEM 3T

Lot or serial number

More than 100 numbers, contact manufacturer.

Model or catalog number
  • "16-02-81
  • 16-02-82
  • 16-02-85"
Companies
Manufacturer
Sorin Group Deutschland GMBH
LINBERGHSTRASSE 25
MUNICH
80939
GERMANY