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U.S. Department of Health and Human Services

Class 2 Device Recall CDI 100

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  Class 2 Device Recall CDI 100 see related information
Date Initiated by Firm November 01, 2010
Date Posted April 11, 2011
Recall Status1 Terminated 3 on April 17, 2012
Recall Number Z-1944-2011
Recall Event ID 57189
510(K)Number K902654  
Product Classification In-line blood-gas sensor - Product Code DTY
Product Terumo Cardiovascular Systems Corporations, CDI 100 Hematocrit/ Oxygen Saturation Monitoring System. In-line blood-gas sensor used in cardiopulmonary bypass.
Code Information 100-001 through 100-1687
Recalling Firm/
Terumo Cardiovascular Systems Corporation
6200 Jackson Road
Ann Arbor MI 48103-9586
For Additional Information Contact Tracy Bellanca
Manufacturer Reason
for Recall
Inaccurate result. Possibility for displayed values for potassium, CO2, hematocrit, O2 saturation, pH, hemoglobin and other measured blood parameters to be inaccurate.
FDA Determined
Cause 2
Device Design
Action On 11/1/2010, Terumo sent "URGENT MEDICAL DEVICE CORRECTION" notices to Chief Perfusionist, Department of Cardiovascular Surgery or Director of Operating Room Services. The letter informed the consignees about the incidents of the CDI 100 and 101 displaying inaccurate values. The letter states that when a displayed value is significantly different from expectations based on the clinical situation, the user should verify the accuracy by independent means before treating. The letter included "Caution" stickers that were to be applied to the CDI system operators manual.
Quantity in Commerce 1032 units
Distribution US, India, Colombia, Taiwan, Venezuela, Vietnam, Puerto Rico, Malaysia, Sri Lanka, Brazil, Indonesia, Pakistan, Chile, Germany, Hong Kong, Japan, AE, Singapore, Austria, Belgium and Thailand.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = DTY and Original Applicant = 3M HEALTH CARE, LTD.