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FDAFDA · Food and drugs·Recall number Z-1832-2015

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.

Published July 1, 2015 · Recall initiated: May 15, 2015

Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

Potential component failure causing device inoperability

What to do

Voluntary: Firm initiated · Letter

Recall details

Manufacturer
ArthroCare Medical Corporation
Distributor
US Nationwide Distribution
Lot
Lot Numbers: 1092289, 1092288, 1092287, 1092284, 1092276, 1085237 (Expiration date: 09JAN2017)
Risk classification
Class II
Area (FDA)
device
Country
United States

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