Recall Z-2188-2011 ยท DRY Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass
Terumo Cardiovascular Systems Corporation
CDI Blood Parameter Monitoring System 500 with Arterial Blood parameter module Catalog number 500A , Terumo Cardiovascular Systems Corporations, Ann Arbor, MI. The CDI 500 is indicated for use to display patient blood gas values during extracorporeal procedures. The CDI 500 system is a stand alone systems that is used during extracorporeal procedures to continuously monitor the blood in th
| Date | May 12, 2011 (initiated Nov 1, 2010) |
| Status | Terminated |
| Reason | The CDI 500 monitors may display inaccurate values. These errors include inaccurate potassium, CO2, hematocrit, O2 saturation, pH, hemoglobin and other miscellaneous inaccurate values. |
| Root 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 let |
| Quantity | 3260 all products |
| 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, Trini |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K972962 | 3M CDI BLOOD PARAMETER MONITORING SYSTEM 500 3M Company, Nov 6, 1997 |