Class 2 Device Recall Electrosurgical pencil.

• Date Initiated by Firm: April 06, 2006
• Date Posted: April 19, 2006
• Recall Status: Terminated on August 03, 2006
• Recall Number: Z-0778-06
• Recall Event ID: 35124
• 510(K)Number: K965054
• Product Classification: Electrosurgical, Cutting & Coagulation & Accessories - Product Code GEI
• Product: Rocker Switch Electrosurgical Pencil with E-Z Clean Tip
• Code Information: Catalog Number 0030H. Lot numbers: 51269, 51270, 51271, 51272, 51273, 60101, 60102.
• FEI Number: 1721194
• Recalling Firm/ Manufacturer: Megadyne Medical Products, Inc; 11506 S State St; Draper UT 84020-9453
• For Additional Information Contact: 800-747-6110
• Manufacturer Reason for Recall: Surgical device packaging may be damaged and may compromise sterility.
• FDA Determined Cause: Other
• Action: Consignees were notified by letter on 04/06/2006.
• Quantity in Commerce: 34,132 units
• Distribution: Nationwide, including one VA facility in OH. No military consignees. Foreign distribution to France, India, Ireland, Japan, South Korea, Malaysia, Poland, UK.
• 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