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CDI Blood Parameter Monitoring System 500 (August 22, 2013)

Starting date:
August 22, 2013
Posting date:
August 22, 2013
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type III
Source of recall:
Health Canada
Issue:
Product Safety
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-35539

Reason

Investigation into complaints concerning the accuracy of the displayed parameters revealed that users may not be aware that the displayed values could be drifting or inaccurate, particularly if the user does not follow all of the instructions for use for the device.

Affected products

A. CDI Blood Parameter Monitoring System 500 with Arterial Blood Parameter Module and Hematocrit / Saturation Probe

Lot or serial number

1000-6046

Model or catalog number

500A HCT, 500 AV HCT

Companies

Manufacturer
Not Applicable



B. CDI Blood Parameter Monitoring System 500 with Arterial and Venous Blood Parameter Modules and Hematocrit / Saturation Probe

Lot or serial number

1000-6046

Model or catalog number

500A HCT, 500 AV HCT

Companies

Manufacturer
Not Applicable