Z-0675-2012

CDI Blood Parameter Monitoring System 500

Name: Z-0675-2012 CDI Blood Parameter Monitoring System 500
Creator: Terumo Cardiovascular Systems Corporation
Published: 2011-12-06
License: https://open.fda.gov/license/

Terumo Cardiovascular Systems Corporation / initiated 2011-12-06 / Terminated / root cause: manufacturing process

FDA source

Terumo Cardiovascular Systems Corporation began a recall of CDI Blood Parameter Monitoring System 500 Product Usage: The CDl Blood Parameter Monitoring System 500 is intended for use during cardiopulmonary bypass... on 2011-12-06. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0675-2012
Status: Terminated
Initiated: 2011-12-06
Posted: 2012-01-11
Terminated: 2013-03-01
Recalling firm: Terumo Cardiovascular Systems Corporation
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.
Product code: DRY Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass
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
Root cause tag: manufacturing process
FDA root cause: 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.
Product codes and lots: Catalog Number: 500A CDI Blood Parameter Monitoring System 500 with Arterial blood parameter module.

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)