Z-1380-2012

CDI Blood Parameter Monitoring System 500, 500AV. Intended for use during cardiopulmonary bypass procedures

Name: Z-1380-2012 CDI Blood Parameter Monitoring System 500, 500AV. Intended for use during cardiopulmonary bypass procedures
Creator: Terumo Cardiovascular Systems Corporation
Published: 2012-02-03
License: https://open.fda.gov/license/

Terumo Cardiovascular Systems Corporation / initiated 2012-02-03 / Terminated / root cause: labeling and UDI

FDA source

Terumo Cardiovascular Systems Corporation began a recall of CDI Blood Parameter Monitoring System 500, 500AV. Intended for use during cardiopulmonary bypass procedures on 2012-02-03. The reason FDA records is "Replacement of the SBC batteries (system batteries) should be managed as "routine maintenance" instead of as an in-house Service Procedure because some systems may be relying on batteries beyond their useful life". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1380-2012
Status: Terminated
Initiated: 2012-02-03
Posted: 2012-04-06
Terminated: 2013-08-29
Recalling firm: Terumo Cardiovascular Systems Corporation
Product: CDI Blood Parameter Monitoring System 500, 500AV. Intended for use during cardiopulmonary bypass procedures.
Product code: DRY Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass
Reason for recall: Replacement of the SBC batteries (system batteries) should be managed as "routine maintenance" instead of as an in-house Service Procedure because some systems may be relying on batteries beyond their useful life.
Root cause tag: labeling and UDI
FDA root cause: Labeling design
Action: On 2/3/12 all consignees received an URGENT MEDICAL DEVICE RECALL letter via Federal Express. The letter described the reason for the recall, identified the affected product population, what to do in the event of a failure, the potential hazard, and correction. Terumo CVS will update the Operator's Manual for the CDI 500 with instructions to replace the battery within its useful life. Users are to review the notice and ensure that all users are made aware of the issue. In addition, the Customer Response Form should be completed and returned. Users can contact their local Terumo Cardiovascular Systems representative or call 1-800-521-2818 with questions or concerns, to check the last time system batteries were replaced, or to schedule maintenance for systems approaching 10 years.
Quantity in commerce: 3,829 units
Distribution: Worldwide Distribution -- USA, including the states of AK, AL, AR, AZ, CA, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, UT, WV, WA, and WI and the countries of Japan, Germany, Barbados, Saudi Arabia, Columbia, Uruguay, Ecuador, Trinidad, Costa Rica, Paraguay, Panama, Belgium, Jordan, Libya, Mexico, Brazil, Honduras, Canada, Korea, Dominica Republic, El Salvador, Guatemala, Vietnam, Chile, Hong Kong, United Arab Emirates, Singapore, Australia, Malaysia, Taiwan, Philippines, Mexico, Thailand, Vietnam, and South Africa.
Product codes and lots: 500AV CDI Blood Parameter Monitoring System 500 with Arterial and Venous blood parameter modules: 1192, 1193, 1355, 1356, 1420, 1423, 1464, 1465, 1467, 1468, 1483, 1504, 1521-1524, 1526, 1527, 1529, 1530, 1602-1604, 1606, 1662, 2023, 2035, 2102-2107, 2800, 2901, 2902, 3131-3135, 3261, 3262, 4132, 5330-5333, 5338-5340, and 5579.

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)