FDA-Device2016-10-12Class III
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.
Terumo Cardiovascular Systems Corporation
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.
Sold states
Worldwide Distribution - USA (nationwide) Distribution.
Affected count
140,000 units
Manufactured in
125 Blue Ball Rd, N/A, Elkton, MD, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0001-2017Don't want to check this manually?
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