Blue Belt Technologies, Inc. Monitor Drape REF: PFSD-V0001, Rx only, Sterile EO. Product Usage: The intended use of this device is t protect equipment from contamination during a variety of procedures throughout the clinical setting.
Publicado el 28 de agosto de 2013 · Inicio del retiro: 19 de julio 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
Blue Belt Technologies is recalling sterile Monitor Drapes used with their Navio PFS system during orthopedic knee surgery. The drapes are used to cover the Navio PFS system computer monitor and arm assembly and provide a sterile barrier in the surgical suite. The defect is evident when the computer monitor is being draped. The front section of the drape separates from the rest of the drape at
Qué hacer
Voluntary: Firm initiated · Telephone
Detalles del retiro
- Fabricante
- Blue Belt Technologies MN
- Distribuidor
- Worldwide Distribution and US Nationwide in the states of: CA and PA. United Kingdom.
- Lote
- Lot: D130432, expires February 2018
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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