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

  • Model / Serial
    Lot numbers 1093290 and 1091254
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US Nationwide and the countries of Australia, Belgium, Germany, Spain, United Kingdom, Ireland, India, Italy and Singapore.
  • Product Description
    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.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    ArthroCare Corporation, 7000 W William Cannon Dr, Austin TX 78735-8509
  • Manufacturer Parent Company (2017)
  • Source
    USFDA