Terumo Cardiovascular Systems Corporation recalls 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 w…

Recall date

December 11, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0001-2017

FDA classification

Class III

Brand / firm

Terumo Cardiovascular Systems Corporation

Sold / distributed

Worldwide Distribution - USA (nationwide) Distribution.

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.

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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.