Events

Retiro De Equipo (Recall) de Device Recall DISPOSABLE ECG MONITORING ELECTRODES, MODELS 4500,4530, 4533, 4539, 4540, AND 4560

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 ConvaTec.

¿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
    54975
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1431-2010
  • Fecha de inicio del evento
    2010-03-11
  • Fecha de publicación del evento
    2010-04-22
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-06-21
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=89570
  • 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
    electrode, electrocardiograph - Product Code DRX
  • Causa
    In an emergency situation where defibrillation is necessary and electrodes are already in use, the electrodes may malfunction and incorrectly report lack of cardiac activity.
  • Acción
    The one distributor was notified personally on March 9, 2010. All remaining stock was put on hold, and a "URGENT : MEDICAL DEVICE RECALL" letter dated March 11, 2010, was sent to customers. The letter describes the product, problem and action to be taken by customers. All customers were asked to immediately stop distributing and quarantine all recalled lots. The customers were ask to perform a count of recalled product currently in inventory, complete and return the Recall Response Form even if no recalled product is in inventory, send a copy of response to distributor in order to receive reimbursement, and to call 1-800-582-6514 for instructions on how to return the recalled product. If you have any questions, please contact Convatec at 908-904-2425.

Device

Device Recall DISPOSABLE ECG MONITORING ELECTRODES, MODELS 4500,4530, 4533, 4539, 4540, AND 4560
  • Modelo / Serial
    Model Number 4560M; Lots: 706268, 708152, 709705, 711967, 713648, 713977, 714391, 714392, 714685, 714687.
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide distribution: CA
  • Descripción del producto
    Unilect ECG Electrodes || Unomedical, McAllen Texas. || Intended use:Cardiac monitoring
  • Manufacturer
    ConvaTec

Manufacturer

ConvaTec
  • Dirección del fabricante
    ConvaTec, 200 Headquarters Park Dr, Skillman NJ 08558
  • Empresa matriz del fabricante (2017)
    Triona Holding Sa
  • Source
    USFDA