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U.S. Department of Health and Human Services

Enforcement Report - Week of July 18, 2012

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Product Detail

Product Description 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.
Recall Number Z-1991-2012
Classification Class II
Code Info Model Number: 75800, Lot Numbers: 023392 and 022438
Product Distributed Qty 725 units (125=Lot #023392 & 600 units Lot #022438)
Reason For Recall 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.

Event Detail

Event Id 62332
Product Type Devices
Status Ongoing
Recalling Firm PSC Industries Inc
City Louisville
State KY
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-06-05
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide Distribution-including DC and the states of CA, GA, IN, KY, LA, MT, TX, UT, and WI.