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Sarns Centrifugal System
- Starting date:
- November 30, 2012
- Posting date:
- January 7, 2013
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public (GP), Healthcare Professionals
- Identification number:
- RA-16525
Recalled Products
A. Sarns Centrifugal System
Reason
Terumo Cardiovascular Systems (Terumo CVS) has received multiple reports since 2004 of malfunctions related to components of the Sarns Centrifugal System, including the centrifugal system for the Sarns Perfusion System 9000. The reports can be broadly categorized as follows: Loss of forward flow, motor noise/vibration, missing/inaccurate flow data, erratic operation, unexpected error messages/alarms, module reset, and smoke that was seen or smelled.
Affected products
A. Sarns Centrifugal System
Lot or serial number
7098, 7105
Model or catalog number
6381
Companies
- Manufacturer
- Terumo Cardiovascular Systems Corp.