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Terumo Advanced Pefusion System 1 – Base Unit (100/120V)
- Starting date:
- August 9, 2012
- Posting date:
- September 3, 2012
- 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-26349
Recalled Products
- Terumo Advanced Pefusion System 1 – Base Unit (100/120V)
Reason
Terumo Cardiovascular Systems (Terumo CVS) has received multiple reports since September 2008 of various malfunctions of the Sarns Centrifugal System for the Terumo Advanced Perfusion System 1 in which the user was unable to achieve or maintain the desired flow rate. Terumo CVS' investigation revealed that a number of root causes contributed to the failures.
Affected products
A. Terumo Advanced Pefusion System 1 – Base Unit (100/120V)
Lot or serial number
- 0011-0335
- 0337-0610
- 1001-1034
- 1037-1049
- 1100
- 1103-1106
- 1109-1445
- 1447-1450
Model or catalog number
- 801763
Companies
- Manufacturer
-
Terumo Cardiovascular Systems Corp.
6200 Jackson Road
Ann Arbor
48103
Michigan
UNITED STATES