FDAFDA · Alimentos y medicamentos·N.º oficial Z-1990-2012
Button Switchpens, w/Extendable Needle Electrode 2 mm Exposure Single Use Electrosurgical./Extendable Pencils, 510(k) #K936304, Model Number: 75820. The device is packaged in a sterile Tyvek peel pouch within a cardboard box which contains 24 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 carton label for this device has the manufacturer symbol where the expiration date symbol should be. Firm officials met with FDA on 5/17/2012. At which time, they reported various labeling errors for 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: 75820, Lot Number: 019632
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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