Company: Terumo Cardiovascular Systems Corporation
Date of Enforcement Report: 7/24/2013
Class ll:
PRODUCT
CDI Blood Parameter Monitoring System 500 with Arterial and Venous blood parameter modules and Hematocrit/Saturation probe. Intended for use during cardiopulmonary bypass procedures when continuous monitoring of arterial and/or venous pH, PCO2, PO2, K+, oxygen saturation, hematocrit, hemoglobin, and temperature are desired. Recall Numbesr Z-1730-2013, Z-1731-2013, Z-1732-2013, Z-1733-2013, Z-1734-2013
REASON
Terumo discovered through its own testing that CDI 500 Blood Parameter Monitoring System software contains unused (turned off) accuracy correction factors for slope (gain) and offset (bias) for Hematocrit/Saturation calculations
RECALLING FIRM/MANUFACTURER
Terumo Cardiovascular Systems Corporation, Ann Arbor, MI on 2/27/2013. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
3972 units since 4/26/12
DISTRIBUTION
Nationwide and Internationally
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