Events

Retiro De Equipo (Recall) de Device Recall Kopans Breast Lesion Localization Needle

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Cook Inc..

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    73083
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1028-2016
  • Fecha de inicio del evento
    2016-01-08
  • Fecha de publicación del evento
    2016-02-29
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-03-23
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=143030
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Needle, tumor localization - Product Code MIJ
  • Causa
    Product potentially exposed to body fluids during processing. potential adverse events that may occur as a result of the foreign matter include blood borne pathogen transmission. however, the risk of transmission of blood borne pathogens is thought to be minimal to non-existent since these devices were sterilized after the potential exposure to body fluids.
  • Acción
    Cook Medical sent an URGENT: MEDICAL DEVICE RECALL dated January 8, 2016, to all affected customers via courier with instructions for identifying and returning the affected product. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. Customers were instructed to do the following: Please review the attached list of affected products and lot numbers shipped to your account, and quarantine any affected product that remains unused. 2. Immediately collect and return all unused affected products to Cook Medical as soon as possible for credit. 3. Please complete the attached Recall Response Form and return to Cook Medical either with the product or separately. 4. Please report any Adverse Event to Cook Medical Customer Relations 1-800- 457-4500 or 1-812-339-2235. Monday through Friday between 7:30 a.m. and 5:00 p.m. Eastern Daylight Time or email at FieldActionsNA@Cookmedical.com Should you have any questions or concerns, please do not hesitate to contact Cook Medical Customer Relations at (800) 457-4500 or 1(812) 339-2235.

Device

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
    General and Plastic Surgery Devices
  • 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
    Cook Inc.

Manufacturer

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