Device Recall Kopans Breast Lesion Localization Needle

  • Modèle / numéro de série
    Catalog # DKBL-20-7.0-A Lot # 6215428 date of manufacture 09/17/2015
  • Classification du dispositif
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide distribution including AZ, CA, GA, IL, MO, MS, MT, NC, NH, NY, OH, OK, and PA..
  • Description du dispositif
    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

Fabricant

  • Adresse du fabricant
    Cook Inc., 750 N Daniels Way, Bloomington IN 47404-9120
  • Société-mère du fabricant (2017)
  • Source
    USFDA