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U.S. Department of Health and Human Services

Class 2 Device Recall EVac 70 XTRA with Integrated Cable and PROcise EZ View with Integrated Cable

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  Class 2 Device Recall EVac 70 XTRA with Integrated Cable and PROcise EZ View with Integrated Cable see related information
Date Initiated by Firm June 02, 2015
Date Posted July 18, 2015
Recall Status1 Terminated 3 on June 27, 2016
Recall Number Z-2105-2015
Recall Event ID 71468
510(K)Number K070374  K142999  
Product Classification Electrosurgical, cutting & coagulation & accessories - Product Code GEI
Product EVac 70 XTRA with Integrated Cable and PROcise EZ View with Integrated Cable

Product Usage:
PLASMA WAND devices are indicated for ablation, resection, and coagulation of soft tissue and hemostasis of blood vessels in otorhinolaryngology (ENT) surgery including: adenoidectomy, cysts, head, neck, oral, and sinus surgery, mastoidectomy, myringotomy with effective hemorrhage control, nasal airway obstruction be reduction of hypertrophic nasal turbinates, nasopharyngeal/laryngeal indications including tracheal procedures, laryngeal polypectomy, and laryngeal lesion debulking, neck mass, papilloma keloids, submucosal palatal shrinkage, submucosal tissue shrinkage, tonsillectomy (including palatine tonsils), traditional uvulopalatoplasty (RAUP), tumors, and tissue in the uvula/soft palate for the treatment of snoring. It is intended for procedures using a conductive media, such as normal saline or Ringers lactate.
Code Information Lot numbers 1093290 and 1091254
Recalling Firm/
Manufacturer		 ArthroCare Corporation
7000 W William Cannon Dr
Austin TX 78735-8509
Manufacturer Reason
for Recall		 Wands inspected with the adaptor fixture were released to the field not meeting the dielectric (Hipot) specifications.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action Smith&Nephew sent an Urgent Notification letter dated June 10, 2015 via mail/courier service with delivery tracking/confirmation to affected customers. A response form is included in the notification letter. A follow up letter will be sent to non-responding consignees. Customers were instructed to complete the acknowledgement form and return via fax or email.
Quantity in Commerce 733 devices
Distribution Worldwide Distribution - US Nationwide and the countries of Australia, Belgium, Germany, Spain, United Kingdom, Ireland, India, Italy and Singapore.
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.
510(K)s with Product Code = GEI and Original Applicant = ArthroCare Corporation
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