Hemodynamic monitoring system recalled over fire hazard

Recall date

January 5, 2018

Source

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

Official notice title

ICU Medical, Inc. recalls Hemodynamic monitoring system (HMS), comprised of a Patient Interface Module (Part Number 58401-000 and a User Interfac…

Recall number

Z-1775-2018

FDA classification

Class II

Brand / firm

ICU Medical, Inc.

Sold / distributed

Distributed to the states of CA, FL, NC, NE, NY, and WA.

Why it was recalled

When continuous cardiac output monitoring with a pulmonary artery catheter is placed in the Pause mode, the catheter thermal coil may continue while in pause mode.

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

What was recalled

Hemodynamic monitoring system (HMS), comprised of a Patient Interface Module (Part Number 58401-000 and a User Interface Module (Part Number 58403-000). Intended for patients for whom the monitoring of continuous cardiac output is indicated for diagnostic and prognostic evaluation by a clinician in the hospital.