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U.S. Department of Health and Human Services

Class 3 Device Recall EZ Clean Electrosurgical Electrodes

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 Class 3 Recall
EZ Clean Electrosurgical Electrodes
see related information
Date Posted December 03, 2009
Recall Status1 Terminated on February 17, 2010
Recall Number Z-0486-2010
Recall Event ID 53555
Premarket Notification
510(K) Number
K081791 
Product Classification Electrosurgical, Cutting & Coagulation & Accessories - Product Code GEI
Product E-Z CLEAN Non Stick Cautery Tip. Label reads in part: "MEGADYNE 11506 SOUTH STATE STREET DRAPER, UTAH 84020 USA***CAT/REF 0029M E-Z CLEAN NON STICK CAUTERY TIP***STERILE *** Expiration Date: 2104-07***" The device is intended to conduct monopolar electrosurgical energy from an electrosurgical generator to target tissue during general surgical procedures. This device is intended to be used whenever monopolar electrosurgical cutting and coagulation are indicated.
Code Information Lot Number: 91469.
Recalling Firm/
Manufacturer
Megadyne Medical Products, Inc.
11506 S State St
Draper, Utah 84020-9453
For Additional Information Contact Ronda K. Magneson/Kevin Medina
800-747-6110
Manufacturer Reason
for Recall
Product labels reference an incorrect expiration date. Expiration date referenced on labels is 2104-07 instead of 2014-07.
FDA Determined
Cause 2
PRODUCTION CONTROLS: Error in Labeling
Action A notification letter dated October 13, 2009 was sent to the first level consignees. Consignees were instructed to examine their stock, remove affected product and contact Megadyne Customer Service at 1-800-747-6110 (United States) or 1-801-576-9669 for product return instructions.
Quantity in Commerce 324 units
Distribution Worldwide Distribution -- United States (CA, FL, NE, LA, MT, OK, OR, PA, SC and UT) and New Zealand.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = GEI and Original Applicant = MEGADYNE MEDICAL PRODUCTS, INC.
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