Events

Retiro De Equipo (Recall) de Device Recall ENCORE(R) UNDERGLOVE

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 Ansell Healthcare Products 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
    59155
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2840-2011
  • Fecha de inicio del evento
    2011-06-10
  • Fecha de publicación del evento
    2011-07-18
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-01-10
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=101413
  • 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
    Powder free latex surgeons gloves - Product Code NPD
  • Causa
    Gloves do not meet the tensile requirements of astm d 3577 reducing the shelf life of the product from 5 years to 2 years.
  • Acción
    Ansell Healthcare Products LLC sent an Urgent Voluntary Recall letter dated June 9, 2011, to all affected customers on June 10 and 13, 2011. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to disconstinue use and distribution of any of the affected product and return them to the firm. If the customer distributed gloves further, customers were advised to forward a copy of the notification letter along with their tracking number to their customers. Customers were instructed to complete and return the attached Response Form to Ansell by fax at 1-800-722-8155. Returned product would be replaced or credited to the customer.

Device

Device Recall ENCORE(R) UNDERGLOVE
  • Modelo / Serial
    All codes distributed from February 2008 through May 2011
  • Distribución
    Nationwide Distribution
  • Descripción del producto
    ENCORE(R) UNDERGLOVE, Latex, Powder-Free, Smooth Surgical Gloves, REF 2018490, Size 9, Sterile, Manufactured for Ansell Healthcare, 1635 Industrial Road, Dothan, AL 36303, Made in Sri Lanka || Surgical gloves
  • Manufacturer
    Ansell Healthcare Products LLC

Manufacturer

Ansell Healthcare Products LLC
  • Dirección del fabricante
    Ansell Healthcare Products LLC, 1635 Industrial Rd, Dothan AL 36303-5750
  • Empresa matriz del fabricante (2017)
    Ansell Ltd.
  • Source
    USFDA