Z-0001-2017Class III

CDI H/S Cuvette The intended use for the CDI H IS Cuvette is as follows: The CDI H/S Cuvettes are intended...

Name: Z-0001-2017 CDI H/S Cuvette The intended use for the CDI H IS Cuvette is as follows: The CDI H/S Cuvettes are intended...
Creator: Terumo Cardiovascular Systems Corporation
Published: 2015-12-11
License: https://open.fda.gov/license/

Terumo Cardiovascular Systems Corporation / initiated 2015-12-11 / Terminated

FDA source

Terumo Cardiovascular Systems Corporation began a recall of CDI H/S Cuvette The intended use for the CDI H IS Cuvette is as follows: The CDI H/S Cuvettes are intended for use with a CDI monitor during cardiopulmonary... on 2015-12-11. FDA classified it as Class III and gives the reason as "Terumo Cardiovascular Systems (Terumo CVS) has received complaints of the CDI System 500 monitor displaying the H/S DISCONNECT AT CUVETTE error message when the CDI H/S Cuvette does not make a proper connection to the...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0001-2017
Classification: Class III
Status: Terminated
Initiated: 2015-12-11
Posted: 2016-10-03
Terminated: 2016-10-26
Recalling firm: Terumo Cardiovascular Systems Corporation
Product: CDI H/S Cuvette The intended use for the CDI H IS Cuvette is as follows: The CDI H/S Cuvettes are intended for use with a CDI monitor during cardiopulmonary bypass procedures when continuous monitoring of blood hematocrit and oxygen saturation is desired.
Product code: DRY Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass
Reason for recall: Terumo Cardiovascular Systems (Terumo CVS) has received complaints of the CDI System 500 monitor displaying the H/S DISCONNECT AT CUVETTE error message when the CDI H/S Cuvette does not make a proper connection to the CDI H/S Probe. In this situation, blood parameter values for HCT, Hgb, and SO2 do not display.
FDA root cause: Other
Action: Terumo (Planned Action) plans to execute the following steps as part of the correction activity: Notify all customers of the potential that a cuvette may disengage from the circuit (probe) leading to a "disconnect" message on the monitor. This notification will be performed via a Customer Notification Letter. For further questions, please call (410) 392-7277.
Quantity in commerce: 140,000 units
Distribution: Worldwide Distribution - USA (nationwide) Distribution.
Product codes and lots: 6912 , 6913 6914, 6932, 6933 6934, 6922, 6923 6924, CV-6912, CV-6913, CV-6914 Cardiovascular Procedure Kits- Various

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0001-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0001-2017	Class III	Terminated	Voluntary: Firm initiated	2016-10-12	2016-10-03

Product code DRY

K915265Class IICdi(tm) H/s Cuvette, Modification3M Company / cleared 1992-01-15

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)