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U.S. Department of Health and Human Services

Class 2 Device Recall Minor Surgery Bipolar Cable

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  Class 2 Device Recall Minor Surgery Bipolar Cable see related information
Date Initiated by Firm September 07, 2016
Create Date December 13, 2016
Recall Status1 Terminated 3 on June 18, 2018
Recall Number Z-0748-2017
Recall Event ID 75351
510(K)Number K123366  
Product Classification Electrosurgical, cutting & coagulation & accessories - Product Code GEI
Product ellman A CYNOSURE COMPANY Minor Surgery Bipolar Cable, Contents: Five (5) Disposable Bipolar Cables,STERILE
The Minor Surgery Bipolar Cable is an accessory that is used to connect the bipolar handpieces to the RF generator for electrosurgical procedures that require the bipolar waveform.
Code Information Lot Numbers 45572 (Box), (Individual packages) 48543, 50382, 48543, 50704, 50858 Exp Date - 2018-02
Recalling Firm/
Manufacturer		 Ellman International, Inc.
400 Karin Ln
Hicksville NY 11801-5352
For Additional Information Contact Connie Hoy
516-267-6502
Manufacturer Reason
for Recall		 Mislabeling of the "expiration date". The expiration date on the outer box and the individual pouches do not match. The expiration date on the box is correct with a date of 2018-02.
FDA Determined
Cause 2		 Employee error
Action Cynosure, Inc. dba Ellman distributed Urgent Medical Device Recall Notices dated September 6, 2016, and response forms to their customers via UPS overnight. Cynosure has identified an error in the Expiration Date on the label of the Minor Surgery Bipolar Cable pouch. The Expiration Date on the individual pouches that are provided in the 5 pack boxes do not match the Expiration Date on the box. The Expiration Date on the box is correct with a date of 2018-02, but the label on the individual pouches has a date of 2021-02. Actions To Be Taken - Return any cables subject to recall. You will be contacted by a Cynosure Customer Service Representative who will provide you with a RMA number for any cables that are being returned. Complete and return the response form via email to choy@cynosure.com. Cynosure will replace affected products at no charge upon receipt of the returned cables. Customers with questions should call 978-256-4200 or 800-886-2966. For questions regarding this recall call 516-267-6502.
Quantity in Commerce 370 boxes (US - 159 boxes, OUS - 211 boxes)
Distribution Worldwide Distribution - US including CA, FL, MA, MD, MI, MN, MS, OH, PA, VA, TX & WV; **International**Australia, Bangladesh, Greece, Italy, Japan, Lebanon, Russian Federation, Singapore, Spain & Vietman.
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 = ELLMAN INTERNATIONAL, INC.
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