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CDI Monitoring Systems – Terumo Products
- Starting date:
- April 21, 2012
- Posting date:
- September 3, 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-23823
Recalled Products
- CDI Blood Parameter Monitoring System 500
- CDI System 100 Hematocrit/Saturation Monitoring System
- CDI 101 Blood HCT/Oxygenation Monitor
Reason
Presence of methylene blue can interfere with the readings provided by the CDI System.
Affected products
A. CDI Blood Parameter Monitoring System 500
Lot or serial number
1000 to 4371
Model or catalog number
500
Companies
- Manufacturer
-
Terumo Cardiovascular Systems Corp.
B. CDI System 100 Hematocrit/Saturation Monitoring System
Lot or serial number
100-001 to 100-1687
Model or catalog number
100
Companies
- Manufacturer
-
Terumo Cardiovascular Systems Corp.
C. CDI 101 Blood HCT/Oxygenation Monitor
Lot or serial number
1070 to 1697
Model or catalog number
101
Companies
- Manufacturer
-
Terumo Cardiovascular Systems Corp.