Z-0001-2017 Class III Terminated
FDA device recall Z-0001-2017 was initiated by Terumo Cardiovascular Systems Corporation on Dec 11, 2015 and is designated Class III. 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… The recall status is terminated (terminated Oct 26, 2016). Affected quantity: 140,000 units.
Recall Details
- Product Type
- Devices
- Report Date
- Oct 12, 2016
- Initiation Date
- Dec 11, 2015
- Termination Date
- Oct 26, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 140,000 units
Product Description
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.
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.
Distribution Pattern
Worldwide Distribution - USA (nationwide) Distribution.
Code Information
6912 , 6913 6914, 6932, 6933 6934, 6922, 6923 6924, CV-6912, CV-6913, CV-6914 Cardiovascular Procedure Kits- Various
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0001-2017
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026