Z-2189-2011

CDI Blood Parameter Monitoring System 500 with Venous Blood parameter module Catalog number 500V , Terumo...

Name: Z-2189-2011 CDI Blood Parameter Monitoring System 500 with Venous Blood parameter module Catalog number 500V , Terumo...
Creator: Terumo Cardiovascular Systems Corporation
Published: 2010-11-01
License: https://open.fda.gov/license/

Terumo Cardiovascular Systems Corporation / initiated 2010-11-01 / Terminated / root cause: design

FDA source

Terumo Cardiovascular Systems Corporation began a recall of CDI Blood Parameter Monitoring System 500 with Venous Blood parameter module Catalog number 500V , Terumo Cardiovascular Systems Corporations, Ann Arbor, MI... on 2010-11-01. The reason FDA records is "The CDI 500 monitor may display inaccurate values. These errors include inaccurate potassium, CO2, hematocrit, O2 saturation, pH, hemoglobin and other miscellaneous inaccuracate values". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2189-2011
Status: Terminated
Initiated: 2010-11-01
Posted: 2011-05-12
Terminated: 2014-07-31
Recalling firm: Terumo Cardiovascular Systems Corporation
Product: CDI Blood Parameter Monitoring System 500 with Venous Blood parameter module Catalog number 500V , 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 the extracorporeal circuit, providing ongoing information about the blood parameters.
Product code: DRY Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass
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.
Root cause tag: design
FDA 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 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.
Product codes and lots: 1564, 1565 and 1566.

Product code DRY

K972962Class II3M Cdi Blood Parameter Monitoring System 5003M Company / cleared 1997-11-06

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)