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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
Recalled October 12, 2016 · FDA recall Z-0001-2017 · Terumo Cardiovascular Systems
Hazard
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 Class III
Units
140,000 units
Sold at
Worldwide Distribution - USA (nationwide) Distribution.
Description
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.
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.
Manufacturer(s)
Terumo Cardiovascular Systems Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →