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SORIN HEATER COOLER SYSTEM 3T (2015-06-12)
- Starting date:
- June 12, 2015
- Posting date:
- July 8, 2015
- 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-54106
Recalled Product
A. SORIN HEATER COOLER SYSTEM 3T
Reason
Sorin has become aware that the actual disinfection practices and water maintenance by some users has not been conducted according to the IFU. Without this, organisms like mycobacteria can multiply in the heater cooler device and potentially form biofilm. Fluid leakage or aerosolization generated by a contaminated water circuit during device operation could result in patient contact and a contaminated surgical site.
Affected products
A.SORIN HEATER COOLER SYSTEM 3T
Lot or serial number
>100 NUMBERS, CONTACT MFR
Model or catalog number
- 16-02-81
- 16-02-82
- 16-02-85
Companies
- Manufacturer
- Sorin Group Deutschland GMBH