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U.S. Department of Health and Human Services

Class 2 Device Recall EZ Clean Disposable Laparoscopic Electrode

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 Class 2 Recall
EZ Clean Disposable Laparoscopic Electrode
see related information
Date Posted August 27, 2013
Recall Status1 Terminated on January 28, 2014
Recall Number Z-2097-2013
Recall Event ID 65995
Premarket Notification
510(K) Number
K913281 
Product Classification Electrosurgical, Cutting & Coagulation & Accessories - Product Code GEI
Product E-Z Clean® Disposable Laparoscopic Electrode Model Number 0100L and 0100LS. Expiration dates of 05/2018 to 07/2018. Sterile. RX ONLY. This product is packaged individually in a chevron Tyvek® - polyester peel pouch, 6 pouches per box. The E-Z Clean laparoscopic electrode is intended to conduct monopolar electrosurgical energy from an electrosurgical generator to target tissue during laparoscopic surgical procedures. This device is intended to be used whenever monopolar electrosurgical cutting and coagulation are indicated.
Code Information Model: 0100L, Lots: 131508, 131945, 132167, 132396 Model: 0100LS, Lots: 131509, 131946, 132058
Recalling Firm/
Manufacturer
Megadyne Medical Products, Inc.
11506 South State Street
Draper, Utah 84020-9453
For Additional Information Contact Ronda K. Magneson
801-576-9669 Ext. 805
Manufacturer Reason
for Recall
Megadyne Medical Products is recalling certain lots of E-Z Clean, L-Wire laproscopic Electrode Standard Stem and Split Stem due to potential breach of insulation.
FDA Determined
Cause 2
PRODUCTION CONTROLS: Process Control
Action Megadyne sent an Urgent: Medical Device Recall Field Safety Notice dated August 7, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customer were also notified with follow-up phone calls and email beginning on August 7, 2013. Customers were instructed to examine their stock immediately to determine if you have any of the products from the affected lots on hand. If so, please remove form service/discontinue use and contact Megadyne Customer Service at 1 (801) 576-9669 or (800) 747-6110 (USA) for return authorization and replacement or credit.
Quantity in Commerce 1816
Distribution Class II Recall - Worldwide Distribution - US including the states of CA, HI, IL, MN, NC, NJ, OH, PA, TX, UT and VA.
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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