Company:Terumo Cardiovascular Systems Corporation
Date of Enforcement Report 2/20/2013
Class ll:
PRODUCT
Terumo CDI 101 Hematocrit/Oxygen Saturation Monitoring System. Monitors blood/oxygen saturation, hematocrit and hemoglobin levels. Recall Number Z-0802-2013
REASON
Inaccurate readings. Software contains unused (turned off) accuracy correction factors for slope (gain) and offset (bias) for Hematocrit/Saturation calculations. The accuracy on any cuvette size did not meet the specifications.
RECALLING FIRM/MANUFACTURER
Terumo Cardiovascular Systems Corporation, Ann Arbor, MI on 11/1/2010. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
622 units
DISTRIBUTION
Nationwide and Internationally
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