Events

Retiro De Equipo (Recall) de Device Recall Cook Medical

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
    73056
  • Clase de Riesgo del Evento
    Class 1
  • Número del evento
    Z-0800-2016
  • Fecha de inicio del evento
    2016-01-06
  • Fecha de publicación del evento
    2016-02-24
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-08-23
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=142931
  • 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, percutaneous - Product Code DQY
  • Causa
    A manufacturing process may lead to catheter tip fracture and or separation. potential adverse events may include loss of device function, medical intervention to retrieve a separated segment, or complications resulting from a separated tip occluding blood flow to end organs. these catheters are used in venous or arterial pressure monitoring, blood sampling, and administration of drugs and fluids.
  • Acción
    On 1/6/2016, URGENT: MEDICAL DEVICE RECALL notifications were sent to the affected distributors and hospital Risk Management/Recall Administration 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. 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 Medical
  • Modelo / Serial
    RPN/Catalog number: C-PMS-250 C-PMS-2502-15-3.5 C-PMS-2502-15-5.0 C-PMS-250-MONTES-A-092084 C-PMS-251 C-PMS-251J C-PMS-300 C-PMS-300-CHILDRENS-A-032988 C-PMS-300J C-PMS-301 C-PMS-301J C-PMS-301J-PKG C-PMS-400J  Lots: 6028502 6034979 6083984 6194848 NS6014456 NS6014457 6148788 6254047 5906417 6160213 NS6064797 NS6014483 NS6175149 NS6184593 NS6187516 NS6014458 5889463 5898283 5922849 5941909 5964565 5976506 6021072 6028497 6143834 6160238 NS5933957 5828147 5941919 NS5932835 NS5932836 NS6050233 NS6072523 NS6108227 NS6130497 5803601 6034985 6075213 NS5833882 NS5892109 NS5892110 NS5919920 NS6021136 NS6054843 NS6072524 NS6075557 NS6082375 NS6108228 NS6148658 6067668
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US Nationwide including DC and PR including the countries of Australia, Germany, China, Chile, Dominican Republic, Panama, Israel, Brazil, Canada
  • Descripción del producto
    Single Lumen Pressure Monitoring Sets and Trays || The subject sets and trays are comprised of a single-lumen uncoated or heparin-coated catheter. Product catalog numbers with heparin coating are designated by the suffix BH.
  • 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