Events

Retiro De Equipo (Recall) de Device Recall Cook Spectrum

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
    75793
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0733-2017
  • Fecha de inicio del evento
    2016-11-28
  • Fecha de publicación del evento
    2016-12-12
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-09-06
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=151288
  • 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
    Catheter,intravascular,therapeutic,short-term less than 30 days - Product Code FOZ
  • Causa
    Cook medical has received reports of the trays containing the incorrect needle, which in some cases could result in the inability to pass a wire guide through the needle. potential adverse events that may occur as a result of utilizing needles of incorrect size include delay in treatment, which could be critical in an emergent situation. there have been no reports of illness or injury associated with this issue.
  • Acción
    Cook Medical sent an Urgent - Medical Device Recall letter dated November 23, 2016. to all affected customers. The letter identified the product the problem and the action needed to be taken. Action to be taken: 1. Please review the attached list of affected products and lot numbers that were shipped to your account and quarantine any affected products that remain unused. 2. Immediately collect and return all unused affected products to Cook Medical as soon as possible for credit. 3. Please complete the attached Acknowledgement and Receipt Form and return it to Cook Medical. 4. Please report any adverse event to Cook Medical Customer Relations at (800) 457-4500 or 1(812) 339-2235, Monday through Friday between 7:30 am and 5:00 pm Eastern Standard Time or e-mail at fieldactionsna@cookmedical.com. Transmission of this notice: This notice must be passed on to appropriate personnel, including down to the user level, within your organization or to any organization where the potentially affected devices have been transferred. 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 Cook Spectrum
  • Modelo / Serial
    catalog number: C-UDLMY-401J-ABRM-HC-FST Lot 6498570 catalog number: C-UTLMY-501J-ABRM-HC-FST Lot 6501835  Exp date 9/30/2018
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    AZ CA DC GA IL LA MN MS NC NV NY OK PA TN TX WI
  • Descripción del producto
    Cook Spectrum Minocycline/Rifampin Impregnated Double Lumen Central Venous Catheter Tray || Cook Spectrum Minocycline/Rifampin Impregnated Triple Lumen Central Venous Catheter Tray
  • 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