Device Recall Kopans Breast Lesion Localization Needle

  • Modelo / Serial
    Catalog # DKBL-20-7.0-A Lot # 6215428 date of manufacture 09/17/2015
  • Clasificación del producto
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Nationwide distribution including AZ, CA, GA, IL, MO, MS, MT, NC, NH, NY, OH, OK, and PA..
  • Descripción del producto
    Kopans Breast Lesion Localization Needle || The Kopans Breast Lesion Localization Needle consists of a bevel-tip needle with centimeter markings and a hookwire. The hookwire features a burnish mark that allows the operator to ensure that the hookwire is within the needle tip during needle manipulation. The Kopans Breast Lesion Localization Needle is intended for preoperative marking of nonpalpable breast lesions.
  • Manufacturer
  • 1 Event

Fabricante

  • Dirección del fabricante
    Cook Inc., 750 N Daniels Way, Bloomington IN 47404-9120
  • Empresa matriz del fabricante (2017)
  • Source
    USFDA