Events

Retiro De Equipo (Recall) de Device Recall FASLOC 6 Foot Disposable Extension Cable with Safe Connect/Screw Down.

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 Remington Medical 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
    67752
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1441-2014
  • Fecha de inicio del evento
    2014-03-05
  • Fecha de publicación del evento
    2014-04-09
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2018-04-09
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=126209
  • 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
    Cable, transducer and electrode, patient, (including connector) - Product Code DSA
  • Causa
    Remington medical discovered an error on the fl-601-97 ifu; part number ifu-rm-0154. specifically, the polarity for the black chuck in the picture is wrong. it shows (+), but should show (-).
  • Acción
    Remington Medical Inc sent an Field Safety Notice dated March 5, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Please be aware that the typographical error described above is included in the FL-601-97 Instructions for Use (RM-0154 Rev 05) provided with the lots that you have received as identified below. RMI has corrected the typographical error in the revised FL-601-97 Instructions for Use (RM-0154 Rev 5.1) which is attached to this communication. Please incorporate the information contained in the attachment with the existing FL-601-97 labeling (Instructions for Use) provided with the product. If you have distributed these products further, please forward copies of this notice and the revised Instructions for Use to any recipients as appropriate. If you have any questions regarding this communication, please contact RMIs sales representatives or customer service team at 800-989-0057, Monday - Friday, between the hours of 8 am - 4pm EST. Patient safety is the highest priority for Remington Medical, Inc. We appreciate your assistance with this matter and regret any inconvenience this may cause.

Device

Device Recall FASLOC 6 Foot Disposable Extension Cable with Safe Connect/Screw Down.
  • Modelo / Serial
    Lot numbers 131901, 132262, 132263, 132533, 132693, 132694, 132833 132835, 132986, and 133171.
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    USA (nationwide) Distribution including Canada
  • Descripción del producto
    FAS-LOC 6 Foot Disposable Extension Cable with Safe Connect/Screw Down. || Electrical extension cable intended to transmit signal from, or power or excitation signal to patient connected electrodes. The cable is a sterile, disposable device.
  • Manufacturer
    Remington Medical Inc.

Manufacturer

Remington Medical Inc.
  • Dirección del fabricante
    Remington Medical Inc., 6830 Meadowridge Ct, Alpharetta GA 30005-2202
  • Source
    USFDA