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FDAFDA · Alimentos y medicamentos·N.º oficial Z-1579-2013

Medtronic SynchroMed II, Model 8637, (The SynchroMed II Pump is supplied in 20 ml or 40 ml reservoir size.) Sterilized using ethylene oxide. The pump is part of an infusion system that stores and delivers a prescribed drug to a specific site. The implantable components of the SynchroMed II infusion system include the pump, catheter,r and catheter accessories The SynchroMed II Programmable Pump is indicated when patient therapy requires the chronic infusion of drugs or fluids:

Publicado el 3 de julio de 2013 · Inicio del retiro: 3 de junio de 2013

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

Medtronic Neuromodulation is providing Healthcare Providers with safety information and patient management recommendations related to the potential for electrical shorting internal to they SynchroMed infusion pump. An electrical short circuit in a feedthrough may present as a motor stall or low battery reset/alarm and lead to a loss of or reduction in therapy which may result in the return of und

Qué hacer

Voluntary: Firm initiated · Visit

Detalles del retiro

Fabricante
Medtronic Neuromodulation
Distribuidor
worldwide
Lote
all SynchroMed II pumps
Clasificación de riesgo
Class I
Área (FDA)
device
País
United States

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