Company: ICU Medical, Inc.
Date of Enforcement Report: 1/20/2021
Class II

PRODUCT

icumedical Cogent” Hemodynamic Monitoring System – 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.

Recall Number: Z-0859-2021

REASON

Due to a potential software issue, the display may show the incorrect continuous cardiac output (CCO) values after PulseCO calibration.

RECALLING FIRM/MANUFACTURER

ICU Medical, Inc. on 11/9/2020. Voluntary:  Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE

220 units

DISTRIBUTION

U.S. Nationwide