Terumo CDI 101 Hematocrit/Oxygen Saturation Monitoring System. Monitors blood/oxygen saturation, hematocrit and hemoglobin levels.
FDA Recall Z-0802-2013 · Posted 2013-02-12
Recalling FirmTerumo Cardiovascular Systems Corporation
Recall StatusTerminated
Product CodeDRY
Date Initiated2010-11-01
Date Terminated2013-11-08
Product Quantity622 units
Reason for Recall
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.
Firm Action
Terumo sent an "URGENT MEDICAL DEVICE CORRECTION" letter dated November 1, 2010 to all affected customers. The letter identified the product, problem, and the actions to be taken by the customers. Contact Terumo CVS Customer Service at 1-800-521-2818 for questions or concerns.
Root Cause
Software design
Distribution Pattern
Worldwide Distribution.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.