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ArthroCare Corporation recalls EVac 70 XTRA with Integrated Cable and PROcise EZ View with Integrated Cable Product Usage: PLASMA WAND devices are
Recalled July 29, 2015 · FDA recall Z-2105-2015 · ArthroCare
Hazard
Wands inspected with the adaptor fixture were released to the field not meeting the dielectric (Hipot) specifications. · FDA Class II
Units
733 devices
Sold at
Worldwide Distribution - US Nationwide and the countries of Australia, Belgium, Germany, Spain, United Kingdom, Ireland, India, Italy and Singapore.
Description
Wands inspected with the adaptor fixture were released to the field not meeting the dielectric (Hipot) specifications.
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.
Manufacturer(s)
ArthroCare Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →