Events

Retiro De Equipo (Recall) de Device Recall AVID Medical QA Pack

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 Avid 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
    79135
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0581-2018
  • Fecha de inicio del evento
    2017-07-03
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2018-04-17
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=161426
  • 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
    General surgery tray - Product Code LRO
  • Causa
    The swab stick collection device provided in a convenience kit expires prior to the kit expiration date.
  • Acción
    Avid Medical began shipping this product on 05/23/2017. Immediately examine your inventory and quarantine all product subject to this correction. In addition, if you may have further distributed this product, please identify your customers and notify them at once of this product correction. Your notification to your customers may be enhanced by including a copy of this Urgent Medical Device Correction notice. Please complete the attached Correction Response Form as soon as possible. Attached is a label template for use in the generation of an appropriate warning label for application on all AV10654-10 inventory of impacted lot 1235229. This label should be applied to each affected convenience kit and product case in a prominently visible location to end-users. The location chosen should not cover any other critical product information found on existing product labeling. If you prefer to have labels printed for your facility, please send quantity and end-user location information request to sharon.moll@owens-minor.com. Replacement component swab stick collection systems are available upon request. This correction will be executed with oversight of the associated account sales rep. Please complete and return the enclosed response form as soon as possible.

Device

Device Recall AVID Medical QA Pack
  • Modelo / Serial
    Avid Medical Kit Lot 1235229 (expiration date 2017-08-01); Swab Stick lots: 5M03A (expiration date 2017-06-03) and 6A21A (expiration date 2017-07-21)
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Seventeen sites located in 13 states: FL, IN, KS, KY, MA, OK, NC, NE, NY, OH, PA, VA, and TX.
  • Descripción del producto
    AVID Medical QA Pack AV10654-10
  • Manufacturer
    Avid Medical, Inc.

Manufacturer

Avid Medical, Inc.
  • Dirección del fabricante
    Avid Medical, Inc., 9000 Westmont Dr, Toano VA 23168-9351
  • Source
    USFDA