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U.S. Department of Health and Human Services

Class 2 Device Recall Electrode Electrosurgical/Extendable Pencil

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  Class 2 Device Recall Electrode Electrosurgical/Extendable Pencil see related information
Date Initiated by Firm June 05, 2012
Date Posted July 11, 2012
Recall Status1 Terminated 3 on January 17, 2014
Recall Number Z-1991-2012
Recall Event ID 62332
510(K)Number K936304  
Product Classification Electrosurgical, cutting & coagulation & accessories - Product Code GEI
Product 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.
Code Information Model Number: 75800, Lot Numbers: 023392 and 022438
Recalling Firm/
Manufacturer		 PSC Industries Inc
3230 Commerce Center Pl
Louisville KY 40211-1900
For Additional Information Contact Victoria Rogers
615-964-5515
Manufacturer 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.
FDA Determined
Cause 2		 Labeling mix-ups
Action Olsen Medical sent an "URGENT:MEDICAL DEVICE RECALL" letter dated June 5, 2012. The letter identifies the product, problem, and actions to be taken by the customers. The letter asks that the customer immediately examine their inventory for the presence of the suspect product and quarantine the product, if found. Customers who may have further distributed the recalled product are asked to contact their (sub-account) customers and notify them of the recall. The customers are also asked to call a toll-free telephone number in order to received a Return Material Authorization (RMA) number and so identify if they would like credit or replacement inventory upon returning the product. The customer is also asked to complete and return the enclosed 'Recall Response Form' and to fax the completed form to the fax number on the form or to send the completed from back to the recalling firm via parcel post.
Quantity in Commerce 725 units (125=Lot #023392 & 600 units Lot #022438)
Distribution Nationwide Distribution-including DC and the states of CA, GA, IN, KY, LA, MT, TX, UT, and WI.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = GEI and Original Applicant = E & M ENGINEERING, INC.
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