FDA recall Z-1775-2018

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.

Reason for recall

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.

Distribution

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

Key facts

Status

Terminated

Initiation date

2018-01-05

Report date

2018-05-16

Termination date

2019-03-18

Voluntary/Mandated

Voluntary: Firm initiated

Location

San Clemente, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1775-2018