Terumo Cardiovascular Systems Corporation recalls CDI 500 Blood Parameter Monitoring System. Provides continuous, on-line monitoring of the extracorporeal partial pressu…

Recall date

August 7, 2015

Source

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

Recall number

Z-2742-2015

FDA classification

Class II

Brand / firm

Terumo Cardiovascular Systems Corporation

Sold / distributed

Worldwide Distribution-US (nationwide) including DC and PR and the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV, and the countries of Australia, Belgium, C…

Why it was recalled

Inaccuracies in SvO2, temperature, pH, pCO2, pO2, Hematocrit, and Potassium readings following a software upgrade to version 1.69.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

CDI 500 Blood Parameter Monitoring System. Provides continuous, on-line monitoring of the extracorporeal partial pressure of oxygen and and carbon dioxide, pH, potassium, oxygen saturation, hematocrit, hemoglobin and temperature.