FDAFDA · Alimentos y medicamentos·N.º oficial Z-1991-2012
Button Switchpens, w/Extendable Needle Electrode 10 mm Exposure, Single Use device, Electrosurgical./Extendable Pencils, 510(k)#K936304, Model Number: 75800. The device is packaged in a sterile Tyvek peel pouch within a cardboard box. The cartons contain 25 pouches per box. Pens/Pencils and Handles -- Olsen Medical Pens/Pencils and handles are designed to hold active electrodes Single Use device intended for coagulating and cutting tissue during surgical procedures.
Publicado el 18 de julio de 2012 · Inicio del retiro: 5 de junio 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
The Tyvek pouch label for this device states: 'with holster'; however, this product does not come with a holster. Firm officials met with FDA on 5/17/2012. At which time, they reported various labeling errors with their Button Switch Pen Electrode Electrosurgical /Extendable Pencils.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- PSC Industries Inc
- Distribuidor
- Nationwide Distribution-including DC and the states of CA, GA, IN, KY, LA, MT, TX, UT, and WI.
- Lote
- Model Number: 75800, Lot Numbers: 023392 and 022438
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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