ICU Medical Recalls Hemodynamic Monitoring Systems Due to Pause Mode Defect

Plain-English summary

ICU Medical, Inc. is recalling 36 Hemodynamic Monitoring Systems (HMS). The recalled devices consist of a Patient Interface Module (Part Number 58401-000) and a User Interface Module (Part Number 58403-000). These systems are intended for patients in hospitals who require continuous cardiac output monitoring for diagnostic and prognostic evaluation.

The recall was initiated because when continuous cardiac output monitoring with a pulmonary artery catheter is placed in the Pause mode, the catheter thermal coil may continue operating while in pause mode. The devices were distributed to the states of California, Florida, North Carolina, Nebraska, New York, and Washington.

Hospitals and healthcare facilities should check their inventory for the specific serial numbers listed in the recall notice. If a device is found, it should be removed from service and returned to ICU Medical, Inc. according to the instructions provided by the manufacturer.

The recalled product

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 evalua

Manufacturer

ICU Medical, Inc.

Category

Medical Device — Cardiac Monitoring

Hazard

• device-malfunction
• thermal-coil

Affected units

36

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Distribution

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