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FDAFDA · Alimentos y medicamentos·N.º oficial Z-1995-2013

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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