CDI TM 101 Monitor, CDI TM 101 Hematocrit/Oxygen Saturation Monitoring System, The CDI TM 101 Hematocrit/Oxygen Saturation Monitoring System is intended for use during cardiopulmonary bypass procedures where you need continuous monitoring of the blood's oxygen saturation, hematocrit and hemoglobin levels.
FDA Recall Z-2610-2011 · Posted 2011-06-22
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Recalling FirmTerumo Cardiovascular Systems Corporation
Recall StatusTerminated
Product CodeDRY
Date Initiated2011-04-28
Date Terminated2012-11-06
Product Quantity622
Reason for Recall
Terumo discovered through its own testing that the presence of electromagnetic interference (EMI) in the operating room may affect the accuracy of the values
displayed by the CDI"101 Hematocrit/Oxygen Saturation Monitoring System: hematocrit (HCT), hemoglobin (Hgb) and Oxygen Saturation.
Firm Action
Terumo Cardiovascular Systems, Corp issued an "URGENT MEDICAL DEVICE CORRECTION" letter dated April 28, 2011, to all affected customers. The letter identifed the product, the problem and the action needed to be taken by the customer.
After a solution has been verified, Terumo CVS will implement a correction for all affected units.
Customers were instructed to review this Medical Device Correction notice, Assure that all users are aware of this notice. Confirm receipt of this and to fax back the Customer Response form.
For further question please contact Terumo CVS Customer Service at 1-800-521-2818, Monday - Friday, 8 AM - 6 PM EST.
Root Cause
Device Design
Distribution Pattern
Worldwide Distribution -- USA ( nationwide) and the countries of Colombia, Vietnam, India, Indonesia, Pakistan, Canada, Chile, Vietnam, Chile, Hong Kong, United Arab Emirates, Singapore, Australia, Malaysia, Singapore, Taiwan, Belgium, Thailand, Vietnam and India
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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