FDAFDA · Food and drugs·Recall number 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.
Published July 18, 2012 · Recall initiated: June 5, 2012
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- PSC Industries Inc
- Distributor
- Nationwide Distribution-including DC and the states of CA, GA, IN, KY, LA, MT, TX, UT, and WI.
- Lot
- Model Number: 75820, Lot Number: 019632
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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