Reported Jan 20, 2021 · Terminated
icumedical Cogent" Hemodynamic Monitoring System - Product Usage: intended for patients for whom the monitoring of…
ICU Medical, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: ICU Medical, Inc. · 951 Calle Amanecer · San Clemente, CA · 92673-6212
Is this the product you have?
- icumedical Cogent" Hemodynamic
- Monitoring System - Product Usageintended for patients for whom the monitoring of continuous cardiac output and calculated hemodynamic parameters is indicated for diagnostic and prognostic evaluation by a clinician
- Lot codes and dates
- List Number/Item Code58400-000
- User Interface Module item58403-000
- Serial Number
406 of 406 codes
TSI701114TSI701129TSI701136TSI701180TSI701179TSH901670TSH200797TSH901640TSH900431TSI701174TSH200801TSH200767TSI701173TSI802195TSH101376TSH200764TSH901982TSH901985TSH901602THS901630TSH901576TSH901639TSH901622TSH901641TSH901620TSH901604TSH901988TSH901595TSH901597TSH901588TSI701113TSI701112TSI701110TSI701115TSI701105TSH900444TSH900449TSH901612TSH901610TSI701177TSI701178TSI701125TSI701127TSI701184TSI701185TSI701186TSI701169TSI701128TSFA01684TSFA01695TSH101367TSH901666TSI701119TSI701120TSH901642TSH901674TSH901662TSH901626TSH901644TSH901627
- TSI802167 List Number/Item Code58400-000R
- User Interface Module item58403-000
- Serial Number
98 of 98 codes
TSH900425TSFA01656TSFA01696TSH101361TSH900451TSH901618TSI701111TSH901574TSFA01686TSH101341TSH101349TSH200742TSH200821TSH200810TSH900419TSH200783TSH900408TSH200786TSFA01697TSH200770TSH101391TSH200748TSFA01666TSH200819THS101345TSH900402TSH900447TSH200769TSH101382TSH200822TSH101344TSFA01687TSFA01677TSH101338TSH200758TSH200744TSFA01659TSH101373TSH200792TSFA01667TSH200824TSH200739TSH200787TSI900357TSH200768TSFA01665TSH101354TSH900405TSH200812TSH900404TSH900439TSH900403TSH900445TSH901665TSH101377TSH200785TSH200779TSHI701057TSFA01657TSH200796
- Amount recalled
- 220 units
Where it was sold
Why it was recalled
Due to a potential software issue, the display may show the incorrect continuous cardiac output (CCO) values after PulseCO calibration.
This product could cause temporary or reversible health problems — stop using it.
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