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ICE CONTAINER (2016-06-16)

Starting date:
June 16, 2016
Posting date:
June 30, 2016
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type II
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
Healthcare Professionals, General Public, Hospitals
Identification number:
RA-59120

Affected products

A. ICE CONTAINER

Reason

In order to further mitigate the potential risk of infection by non-Tuberculous mycobacteria (see Health Canada RA-54106), Sorin (now Livanova) is taking an additional action with respect to the removal of the ice container, which could be a source of contamination of the heater-cooler 3T's water circuit if the user has failed to follow the instructions for use for water maintenance and water circuit disinfection.

Affected products

A. ICE CONTAINER

Lot or serial number

All lots

Model or catalog number

16-02-60

Companies
Manufacturer
Sorin Group Deutschland GMBH
LINBERGHSTRASSE 25
MUNICH
80939
GERMANY