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System 1 Base 100/120v (2013-02-20)
- Starting date:
- February 20, 2013
- Posting date:
- March 18, 2014
- Type of communication:
- Medical Device Recall
- Subcategory:
- Biologic/vaccine
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-38281
Recalled Products
System 1 Base 100/120v
Reason
The roller pump displayed a jam message and stopped while in use. It is more likely to occur when using the 6 inch than using the 4 inch roller pump for dual sized tube set cardioplegia delivery. The occlusion settings suggested in IFU for some dual-sized tubing sets may increase the likelyhood of pump jam on 6 inch roller pump.
Affected products
System 1 Base 100/120v
Lot or serial number
More than 10 numbers, contact manufacturer
Model or catalog number
801763
Companies
- Manufacturer
-
Terumo Cardiovascular Systems Corp.
6200 Jackson Road
Ann Arbor
48103
Michigan
UNITED STATES