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U.S. Department of Health and Human Services

Class 2 Device Recall Coblator II System

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  Class 2 Device Recall Coblator II System see related information
Date Initiated by Firm February 20, 2015
Date Posted March 26, 2015
Recall Status1 Terminated 3 on February 26, 2016
Recall Number Z-1323-2015
Recall Event ID 70594
510(K)Number K030108  
Product Classification Electrosurgical, cutting & coagulation & accessories - Product Code GEI
Product Coblator II System, 120V.

Product Usage: The Coblator II (Model RF8000E) is a bipolar, radiofrequency electrosurgical system designed for use in otorhinolaryngology (ENT) surgery. The system consists of the following components: an electrosurgical radiofrequency controller, a reusable, non-sterile Power Cord; a reusable, non-sterile Foot Control; a reusable, non-sterile Flow control Valve Unit; a reusable, non-sterile flow control cable; a single use, disposable, sterile Wand. The Coblator II is indicated for ablation, resection, and coagulation of soft tissue and hemostasis of blood vessels in otorhinolaryngology (ENT) surgery.
Code Information Serial Numbers: CA0N0000FT, CA0N0000H0, CA0N0000H7, CA0N0000J6, CA0N0000KJ, CA0N0000KK, CA0N0000KL, CA0N0000FW, CA0N0000G5, CA0N0000G6, CA0N0000H1, CA0N0000FR, CA0N0000FZ, CA0N0000KF, CA0N0000GH
Recalling Firm/
Manufacturer		 ArthroCare Medical Corporation
7000 W William Cannon Dr
Austin TX 78735-8509
For Additional Information Contact
512-391-3900
Manufacturer Reason
for Recall		 The recalling firm was notified by the contract manufacturer that they had reversed the L2, L3, L4, or L5 components on the P/N09010 RoHS boards of the Coblator II Controller (Model RF8000E).
FDA Determined
Cause 2		 Packaging process control
Action ArthroCare sent an Urgent Medical Device Recall letter dated February 2015 to customers. A response form will be included in the letter and a follow up notifcation letter will be sent to non-responding consignees. The letter identified the affected product, problem and actions to be taken. For questions contact your local Returns Department Representative at 800-343-5717, option 3.
Quantity in Commerce 15 units
Distribution US Nationwide Distribution in the states of TN, IA, AZ, NE, SD, NY, and OK.
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 = ARTHROCARE CORP.
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