ICU Medical, Inc. recalls The Cogent Hemodynamic Monitoring System. REF58400-000, GTIN 00840619099459; REF 58400-000R, GTIN 0087709094314; REF 58…

Recall date

February 14, 2020

Source

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

Recall number

Z-1927-2020

FDA classification

Class II

Brand / firm

ICU Medical, Inc.

Sold / distributed

US Nationwide distribution including in the states of AR, CA, FL, IL, MD, NC, NE, NY, TX, VT, WA and WI.

Why it was recalled

Firm identified software issues which leads to the patient ID and patient information not being stored in the system.

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

What was recalled

The Cogent Hemodynamic Monitoring System. REF58400-000, GTIN 00840619099459; REF 58400-000R, GTIN 0087709094314; REF 58403, GTIN 00840619079505; REF 58401, GTIN 00840619079499 - Product Usage: intended for patients for whom the monitoring of continuous cardiac output and calculated hemodynamic parameters is indicated for diagnostic and prognostic evaluation by a clinician. The target population includes Critical Care Patients, Trauma Patients, and Cardiac Surgery Patients.