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Health product recall

Terumo Advanced Perfusion System 1 (Electronic Gas Blender/Analyzer and Base Unit)

Starting date:
August 9, 2012
Posting date:
September 17, 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-23857

Recalled Products

  1. Advanced Perfusion System 1 – Electronic Gas Blender/Analyzer
  2. Advanced Perfusion System 1 – Base Unit

Reason

Terumo Cardiovascular Systems (Terumo CVS) received reports of two instances where users were confused about the proper adjustment of the local control knobs of the electronic patient gas system on the Terumo Advanced Perfusion System 1.

Affected products

A. Advanced Perfusion System 1 – Electronic Gas Blender/Analyzer

Lot or serial number

>10 Numbers, contact manufacturer.

Model or catalog number

801188

Companies
Manufacturer
Terumo Cardiovascular Systems Corp.

B. Advanced Perfusion System 1 – Base Unit

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.