FDAFDA · Alimentos y medicamentos·N.º oficial Z-0009-2013
Wound Pro Apex Negative Pressure Wound Therapy Powered Suction Pump; Accuro Medical Products LLC, 2854 Hitchcock Ave, Downers Grove, IL 60515; part number 84635400182, sold inside the Apex Negative Wound Therapy system, part number 84635400181 Promotes wound healing through drainage and removal of infectious material and other fluids from the wound site using continuous and/or intermittent negative pressure. Types of wounds indicated include diabetic/neuropathic ulcers, pressure ulcers, chronic wounds, acute wounds and dehisced wounds.
Publicado el 10 de octubre de 2012 · Inicio del retiro: 31 de agosto de 2012
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
Accuro has received reports of some Apex Pumps either failing to operate or malfunctioning, at times without notifying the user of such failure or malfunction on the unit's display screen.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Accuro Medical Product LLC
- Distribuidor
- Worldwide distribution: USA (nationwide) and country of: Canada.
- Lote
- part number 84635400182, serial numbers E000146 through E002039, (all serial numbers)
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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