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ICU Medical, Inc. recalls Hemodynamic monitoring system (HMS), comprised of a Patient Interface Module (Part Number 58401-000 and a User Interface
Recalled May 16, 2018 · FDA recall Z-1775-2018 · ICU Medical
Hazard
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. · FDA Class II
Units
36 devices
Sold at
Distributed to the states of CA, FL, NC, NE, NY, and WA.
Description
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.
Product
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.
Manufacturer(s)
ICU Medical, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →