Class 2 Device Recall CDI 500 Blood Parameter Monitoring System

• Date Initiated by Firm: November 01, 2010
• Date Posted: May 12, 2011
• Recall Status: Terminated on July 31, 2014
• Recall Number: Z-2187-2011
• Recall Event ID: 57194
• 510(K)Number: K972962
• Product Classification: Monitor, blood-gas, on-line, cardiopulmonary bypass - Product Code DRY
• Product: CDI Blood Parameter Monitoring System 500 with Arterial and Venous blood parameter modules, Catalog 500AV, Terumo Cardiovascular Systems ; ; The CDI 500 is indicated for use to display patient blood gas values during extracorporeal procedures.
• Code Information: 1193, 1355, 1356, 1420, 1423, 1464, 1465, 1504, 1521, 1522, 1523, 1524, 1526, 1527, 1529, 1530, 1602, 1603, 1604, 1606, 1662, 2035, 2102, 2103, 2104, 2105, 2106, 2107, 2800, 2901, 2902, 3131, 3132, 3133, 3134, 3135, 3261, 3262 and 4132.
• Recalling Firm/ Manufacturer: Terumo Cardiovascular Systems Corporation; 6200 Jackson Road; Ann Arbor MI 48103-9586
• For Additional Information Contact: Tracy Bellanca; 734-741-6173
• Manufacturer Reason for Recall: The CDI 500 monitor may display inaccurate values. These errors include inaccurate potassium, CO2, hematocrit, O2 saturation, pH, hemoglobin and other miscellaneous inaccuracate values.
• FDA Determined Cause: Device Design
• Action: The firm, TERUMO, sent an "URGENT MEDICAL DEVICE CORRECTION" letter dated October 27, 2010 to its customers. The letter described the product, problem and actionst to be taken. The customers were instructed to reveiw this notice; assure that customers are ware of this notice; confirm receipt of this notification by faxing the attached Customer Response Form, and place the attached stickers in a visible place in the Operators' Manuals, such as the inside of the front cover, if additional stickers are needed, the customers should contact Terumo CVS Customer Service at 1-800-521-2818. The letter states that when a displayed value is significantly different from expectations based on the clinical situatioin, 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 operatros manual. The letter also states "Please note that we are not recommending that you stop using your CDI monitor system." If you have any questions or concerns, please contact Terumo CVS Customer Service at 1-800-521-2818. Customer Service hours are from Monday-Friday, 8AM - 6PM EST.
• Quantity in Commerce: 3260 all models.
• Distribution: Worldwide distribution: USA (nationwide) and countries of : Australia, Barbados, Belgium, Brazil, Columbia, Costa Rica, Dominican Republic, Ecuador, El Salvador, Guatamala, Hong Kong, Honduras, Jordan, Japan, Libya, Mexico, Malaysia, Panama, PH, Saudi Arabia, Singapore, South Africa, Thailand, Trinidad, Taiwan and Uruguay, Germany, Saudia Arabia, Paraguay, South Korea, Dominican Republic, Phillipines, South Africa and UAE.
• 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 = DRY and Original Applicant = 3M COMPANY