| Class 2 Device Recall CDI 500 Monitor | |
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
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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
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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 |
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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.
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510(K) Database | 510(K)s with Product Code = DRY
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