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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