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ADULT AND PEDIATRIC OXYGENATOR BRACKETS (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:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-59122
Affected products
A. ADULT OXYGENATOR MOUNTING BRACKETS
B. LILLIPUT PEDIATRIC OXYGENATOR BRACKETS
Reason
In order to further mitigate the potential risk of infection by non-Tuberculous mycobacteria (see Health Canada RA-54106), Sorin (now Livanova) is replacing certain oxygenator mounting brackets that are currently being used with the heater-cooler 3T, as they could be a source of re-contamination with non-Tuberculous mycobacteria of a clean heater cooler 3T's water circuit.
Affected products
A. ADULT OXYGENATOR MOUNTING BRACKETS
Lot or serial number
All lots
Model or catalog number
050127
050128
050131
050350
05040
05041
05046
Companies
- Manufacturer
-
Sorin Group Deutschland GMBH
LINBERGHSTRASSE 25
MUNICH
80939
GERMANY
B. LILLIPUT PEDIATRIC OXYGENATOR BRACKETS
Lot or serial number
All lots
Model or catalog number
05049
05061
Companies
- Manufacturer
-
Sorin Group Deutschland GMBH
LINBERGHSTRASSE 25
MUNICH
80939
GERMANY