Device Recall PROcise XP Wand with Integrated Cable

  • Modelo / Serial
    Lot Numbers: 1092290, 1092291, 1092292
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    US Nationwide Distribution
  • Descripción del producto
    PROcise XP Wand with Integrated Cable REF EICA8872-01 || 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.
  • Manufacturer
  • 1 Event

Fabricante

  • Dirección del fabricante
    ArthroCare Medical Corporation, 7000 W William Cannon Dr, Austin TX 78735-8509
  • Empresa matriz del fabricante (2017)
  • Source
    USFDA