Class 2 Device Recall EVac 70 XTRA with Integrated Cable

• Date Initiated by Firm: May 15, 2015
• Date Posted: June 25, 2015
• Recall Status: Terminated on June 27, 2016
• Recall Number: Z-1832-2015
• Recall Event ID: 71311
• 510(K)Number: K142999
• Product Classification: Electrosurgical, cutting & coagulation & accessories - Product Code GEI
• Product: EVAC 70 XTRA with Integrated Cable REF EICA5872-01 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 by 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: 1092289, 1092288, 1092287, 1092284, 1092276, 1085237 (Expiration date: 09JAN2017)
• Recalling Firm/ Manufacturer: ArthroCare Medical Corporation; 7000 W William Cannon Dr; Austin TX 78735-8509
• For Additional Information Contact: Field Action Department; 901-566-7975
• Manufacturer Reason for Recall: Potential component failure causing device inoperability
• FDA Determined Cause: Component design/selection
• Action: Smith & Nephew sent an Urgent Product Recall notification letter dated May 15, 2015 to affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to inspect inventory, quarantine immediately and return to the address listed on the inventory Return Certification Form.
• Quantity in Commerce: 4,111 units
• Distribution: US Nationwide Distribution
• 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