Reported Jul 29, 2015 · Terminated
EVac 70 XTRA with Integrated Cable and PROcise EZ View with Integrated Cable Product Usage: PLASMA WAND devices are…
ArthroCare Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: ArthroCare Corporation · 7000 W William Cannon Dr · Austin, TX · 78735-8509
Is this the product you have?
- EVac 70 XTRA with Integrated Cable and PROcise EZ View
- with Integrated Cable Product UsagePLASMA WAND devices are indicated for ablation, resection, and coagulation of soft tissue and hemostasis of blood vessels in otorhinolaryngology (ENT)
- surgery includingadenoidectomy, 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
- Lot codes and dates
- Lot numbers 1093290 and 1091254
- Amount recalled
- 733 devices
Where it was sold
- Nationwide
Why it was recalled
Wands inspected with the adaptor fixture were released to the field not meeting the dielectric (Hipot) specifications.
This product could cause temporary or reversible health problems — stop using it.
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