FDA Medical Device Recalls (openFDA)
Terumo Cardiovascular Systems Corporation: 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.
- Recall number
- Z-2189-2011
- 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.
- Status
- Terminated
- Initiated
- 2010-11-01
- Posted
- 2011-05-12
- Terminated
- 2014-07-31
- Reason
- 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
- 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
- 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.
- Lot, serial or model codes
- 1564, 1565 and 1566.
- 510(k) numbers
- ["K972962"]
- PMA numbers
- not on file
- Product code
- DRY
- Firm FEI
- 1828100
- Firm city
- Ann Arbor
- Firm state
- MI
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28