Events

Retiro De Equipo (Recall) de Device Recall CaviWipes1 Extra Large

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 Metrex Research, LLC..

¿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
    76318
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1402-2017
  • Fecha de inicio del evento
    2017-01-20
  • Fecha de publicación del evento
    2017-03-03
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-09-01
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=152763
  • 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
    Disinfectant, medical devices - Product Code LRJ
  • Causa
    Metrex is recalling the caviwipes extra large because they may have been contaminated during the packaging process.
  • Acción
    Metrex sent an Urgent Medical Device Recall letter dated January 20, 2017, to all affected customers to inform them that Metrex is recalling one lot of CaviWipes Extra Large because they may have been contaminated during the packaging process. Customers were informed that while handling sealed containers, a production worker sustained a minor finger cut which may have come in contact with the exterior surface of the container. Customers were instructed to contact Metrex Customer care at (800) 537-7123 to receive a RMA number. The RMA will allow for a quick return and replacement or credit. Customers were instructed to identify any customers that may have been shipped the affected product and contact their customers using the customer notification letter that Metrex issued. Metrex requests that those customers contact Metrex Customer Care at (800) 537-7123 and complete the attached acknowledgement form. For questions regarding this recall call 734-947-6700.

Device

Device Recall CaviWipes1 Extra Large
  • Modelo / Serial
    Lot No. 16-2340PA
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution to PA, FL, IL, MN, TX, AL, NY
  • Descripción del producto
    CaviWipes1 Extra Large, Part No. 13-5150 || The brand name of the device is CaviWipes1 Extra Large, a surface disinfectant. The device has been assigned the product code LRJ (General Purpose Disinfectant) by the FDA and is classified as a Class I Medical Device. CaviWipes1 Extra Large is intended to be used to disinfect surfaces.
  • Manufacturer
    Metrex Research, LLC.

Manufacturer

Metrex Research, LLC.
  • Dirección del fabricante
    Metrex Research, LLC., 28210 Wick Rd, Romulus MI 48174-2639
  • Empresa matriz del fabricante (2017)
    Danaher Corporation
  • Source
    USFDA