Device Recall OLYMPUS ViziShot EBUS Aspiration Needle

  • Modelo / Serial
    Models: NA-201SX-4022-A --22 gauge needle: all lot numbers; NA-201SX-4022-B --22 gauge needle: all lot numbers; NA-201SX-4022-C --22 gauge needle: all lot numbers; and NA-201SX-4021 -- 21 gauge needle: all lot numbers.
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution including the District of Columbia and the following States: AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, NE, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VT, VA, WA, WV, WI, and WY.
  • Descripción del producto
    OLYMPUS ViziShot EBUS Aspiration Needle || Endobronchial Ultrasound (EBUS) Needle for Fine Needle Aspiration (FNA) - the needle has been designed to be used with ultrasonic endoscopes for ultrasonically guided fine needle aspiration of submucosal and extramural lesions of the tracheobronchial tree and the gastrointestinal tract.
  • Manufacturer
  • 1 Event

Fabricante

  • Dirección del fabricante
    Olympus America Inc., 3500 Corporate Pkwy., P.O. Box 610, Center Valley PA 18034-0610
  • Empresa matriz del fabricante (2017)
  • Source
    USFDA