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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