FDAFDA · Alimentos y medicamentos·N.º oficial Z-0765-2019
Edwards Lifesciences Swan Ganz Thermodilution Catheter, REF 151F7 Product Usage: The Swan-Ganz Thermodilution Catheter provides a diagnostic tool for physicians to rapidly determine hemodynamic pressures and cardiac output when used with a compatible cardiac output computer. Swan-Ganz thermodilution catheters are indicated for the assessment of a patient s hemodynamic condition through direct intra-cardiac and pulmonary artery pressure monitoring, cardiac output determination, and for infusing solutions. The distal (pulmonary artery) port also allows sampling of mixed venous blood for the assessment of oxygen transport balance and the calculation of derived parameters such as oxygen consumption, oxygen utilization coefficient, and intrapulmonary shunt fraction.
Publicado el 6 de febrero de 2019 · Inicio del retiro: 21 de diciembre de 2018
Estado reportado al momento de publicación: Terminated — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.
Qué peligro representa
These Swan Ganz catheters have incorrect lumen assembly, which causes reversal of the lumens. If the lumens are reversed the clinician may note reverse PA and CVP pressure values and waveforms.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Edwards Lifesciences, LLC
- Distribuidor
- Worldwide Distribution
- Lote
- Lot Numbers: 61176367, 61176370
- Clasificación de riesgo
- Class I
- Área (FDA)
- device
- País
- United States
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