Z-1833-2015 Class II Terminated

Recalled by ArthroCare Medical Corporation — Austin, TX

Recall Details

Product Type
Devices
Report Date
July 1, 2015
Initiation Date
May 15, 2015
Termination Date
June 27, 2016
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
2,355 units

Product Description

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.

Reason for Recall

Potential component failure resulting in inoperability

Distribution Pattern

US Nationwide Distribution

Code Information

Lot Numbers: 1092290, 1092291, 1092292