Events

Retiro De Equipo (Recall) de Device Recall Rusch, Sure Seal Golden Drain, One Piece Urinary Incontinence Device

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 Teleflex Medical.

¿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
    59184
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2831-2011
  • Fecha de inicio del evento
    2011-06-27
  • Fecha de publicación del evento
    2011-07-15
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-03-20
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=101559
  • 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
    Sheath, Corrugated rubber, for nonindwelling catheter - Product Code NNY
  • Causa
    The kit contains skin-prep protective wipes that were manufactured by the triad group and are being recalled by smith & nephew, due to possible bacterial contamination.
  • Acción
    Teleflex Medical sent an "Urgent Medical Device Recall Notification" dated June 27, 2011 to all affected customers. The firm provided recommendations including all affected product be discontinued and quarantined. A Recall Acknowledgement Form was provided to be completed and returned. If the product was further distributed, they were urged to contact their customers and communicate the recall. For additional information please contact Customer Service at 866-246-6990 or your local sales representative.

Device

Device Recall Rusch, Sure Seal Golden Drain, One Piece Urinary Incontinence Device
  • Modelo / Serial
    Catalog number: A1300VA, Lot number: 02E1002552   Catalog number: A1300, Lot number: 02F1001467, 02F1002271, 02F1003283, 02G1000845 and 02G1001302.
  • Clasificación del producto
    Gastroenterology-Urology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution (USA) including the states of FL, GA, OH and SC.
  • Descripción del producto
    Rusch, Sure Seal Golden Drain, One Piece Urinary Incontinence Device, Teleflex Medical. || Used for urine collection.
  • Manufacturer
    Teleflex Medical

Manufacturer

Teleflex Medical
  • Dirección del fabricante
    Teleflex Medical, 4024 Stirrup Creek Dr, Durham NC 27703-9000
  • Empresa matriz del fabricante (2017)
    Teleflex Incorporated
  • Source
    USFDA