Events

Retiro De Equipo (Recall) de Device Recall HOLDEX SingleUse Holder PP

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 Greiner Bio-One North America, 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
    59352
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2957-2011
  • Fecha de inicio del evento
    2011-06-29
  • Fecha de publicación del evento
    2011-08-08
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-11-03
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=102344
  • 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
    Hypodermic Needle Holder, Single Lumen - Product Code FMI
  • Causa
    At removal of the tube from the holder, the needle may dislodge and blood spill can occur.
  • Acción
    Greiner Bio-One North America, Inc. sent a "Recall HOLDEX Single Use Holder PP" letter dated June 29, 2011 to all affected customers. The letter instructed customers stop distributing the product immediately. A Product Disposition form was provided to be completed and returned to Greiner Bio-One at which time upon receipt, arrangements for product return to Greiner Bio-One will be made for replacement or credit. They were requested to provide a list of their customers to Greiner Bio-One that received the affected item. For additional information call Greiner Bio-One at (888) 266-3883.

Device

Device Recall HOLDEX SingleUse Holder PP
  • Modelo / Serial
    Item number: 450263D, Lot number A1008033
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution including the states of CA, GA, IL, KS, MA, IL, PA and VA.
  • Descripción del producto
    HOLDEX Single-Use Holder PP closed pack. || Greiner Bio-One Austria Gmbh. || A sterile single-use disposable holder with an off-center female luer at the top of the holder and epoxy bonded stainless steel needle on the underside of the holder, recommended for use with commercially available butterfly and luer needles in routine venipuncture procedures.
  • Manufacturer
    Greiner Bio-One North America, Inc.

Manufacturer

Greiner Bio-One North America, Inc.
  • Dirección del fabricante
    Greiner Bio-One North America, Inc., 4238 Capital Dr, Monroe NC 28110
  • Empresa matriz del fabricante (2017)
    Greiner Holding Ag
  • Source
    USFDA