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U.S. Department of Health and Human Services

Class 2 Device Recall CDI 500 Monitor

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  Class 2 Device Recall CDI 500 Monitor see related information
Date Initiated by Firm December 06, 2011
Date Posted January 11, 2012
Recall Status1 Terminated 3 on March 01, 2013
Recall Number Z-0675-2012
Recall Event ID 60151
510(K)Number K972962  
Product Classification Monitor, blood-gas, on-line, cardiopulmonary bypass - Product Code DRY
Product CDI Blood Parameter Monitoring System 500

Product Usage: The CDl Blood Parameter Monitoring System 500 is intended for use during cardiopulmonary bypass procedures when continuous monitoring of arterial and/or venous pH, PC02 , P02, K+, oxygen saturation, hematocrit, hemoglobin, and temperature are desired.
Code Information Catalog Number: 500A CDI Blood Parameter Monitoring System 500 with Arterial blood parameter module. 
Recalling Firm/
Manufacturer		 Terumo Cardiovascular Systems Corporation
6200 Jackson Road
Ann Arbor MI 48103-9586
For Additional Information Contact
734-741-6173
Manufacturer Reason
for Recall		 In a recent review of in-house Service Procedures for the CDI Blood Parameter Monitoring System 500, Terumo Cardiovascular Systems (Terumo CVS) found that one of the procedures it had been performing on older systems should have been considered a recall at the time it was implemented: Terumo CVS began installing a protective shield (plastic grommet) in the system chassis during manufacture of all
FDA Determined
Cause 2		 Component change control
Action Terumo sent an "URGENT MEDICAL DEVICE CORRECTION" letter dated December 6, 2011. The letter identified the affected products, the problem, and the actions to be taken by customer/user. The letter states that Terumo CVS will update all affected CDl Monitors and no additional actions are necessary for those units previously returned that received the correction as part of the service process. For questions or concerns contact Terumo CVS Customer Service 1-800-521-2818.
Quantity in Commerce 451 units total
Distribution Worldwide Distribution - USA (nationwide in the states of: AR, AZ, CA, FL, KS, IL, IN, LA, MA, MO, MI, MS, NJ, NV, NC, OH, PA, TN, TX, VA, WA, WI, WV including Puerto Rico and the countries of: AE, Australia, BR, Belgium, Brazil, Canada, China, Dominican Republic, EC, Germany, Guatemala, Japan, Korea, Mexico, SA, Taiwan and UY.
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
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