—#149395

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.

FDA product code: DRY — Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K915265
Affected lot / code info: 6912 , 6913 6914, 6932, 6933 6934, 6922, 6923 6924, CV-6912, CV-6913, CV-6914 Cardiovascular Procedure Kits- Various

Why it was recalled

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.

Root cause (FDA determination)

Other

Action the firm took

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.

Recalling firm

Firm: Terumo Cardiovascular Systems Corporation
Address: 125 Blue Ball Rd, Elkton, Maryland 21921-5315

Distribution

Distribution pattern: Worldwide Distribution - USA (nationwide) Distribution.

Timeline

Recall initiated: 2015-12-11
Terminated: 2016-10-26
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #149395. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.