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Health product recall

TERUMO CUVETTE (2016-01-25)

Starting date:
January 25, 2016
Posting date:
February 8, 2016
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type III
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-57052

Affected Products     

A. TERUMO CUVETTE 

Reason

CDI system 500 monitor displaying the "H/S DISCONNECT AT CUVETTE" error message when the CDI H/S cuvette does not make a proper connection to the CDI H/S probe. In this situation, blood parameter values for Hct, Hgb, and SO2 do not display.

Affected products

A. TERUMO CUVETTE

Lot or serial number

More than 10 numbers, contact manufacturer. 

Model or catalog number
  • 6912
  • 6913
  • 6914
  • 6932
  • 6933
  • 6934
Companies
Manufacturer
Terumo Cardiovascular System Corporation
125 Blue Ball Road
Elkton
21921
Maryland
UNITED STATES