Company: ICU Medical, Inc.
Date of Enforcement Report: 5/7/2020
Class II

PRODUCT

ICU Medical Cogent Hemodynamic Monitoring System, Cogent Item Number 58400-000, UDI: (01)00840619079499

Recall Number: Z-1835-2020

REASON

Firm identified several software issues through internal testing of its Cogent Hemodynamic Monitoring System. These issues may result in inaccurate monitoring data, unit shutdown, and/or loss of display of a secondary parameter.

RECALLING FIRM/MANUFACTURER

ICU Medical, Inc. on 7/12/2019. Voluntary:  Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE

83 units

DISTRIBUTION

U.S. Nationwide