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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
- Date modified: