Events

Retiro De Equipo (Recall) de Gammex

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
    75737
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0893-2017
  • Fecha de inicio del evento
    2016-10-24
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-10-23
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=151121
  • 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
    Surgeon's gloves - Product Code KGO
  • Causa
    Ansell healthcare products is initiating a voluntary recall involving 15 cases of gammex non latex sensitive surgical gloves because the packaged contents incorrectly included a natural rubber latex surgical glove.
  • Acción
    Ansell Healthcare Products, LLC. sent an Urgent: Voluntary Surgical Glove Recall letter dated October 28, 2016, to all affected customers. The letter identified the problem the product and the action the customer needs to take. Please check your product stock at the warehouse and shelf level in order to advise us directly if any gloves having the recalled lot numbers are found. This information, along with your tracking number, must be communicated to our Customer Service Department by calling 1-800-952-9916, or by returning the attached Response Form to Ansell by fax at 1-800-722-8155, or via email customerserviceus@ansell.com . Returned product will either be replaced or credited without delay. Your Ansell representative will be available to follow up with you regarding any concerns you may have.

Device

Gammex
  • Modelo / Serial
    Lot 1607018105
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    US Distribution to the states of : PA, FL, NJ, IL and MA.
  • Descripción del producto
    Gammex Non-Latex Sensitive Neoprene Surgical Gloves || Ansell Lanka (pvt) Ltd. Biyagama Export Processing Zone, Biyagama, Sri Lanka || Ansell Healthcare Europe, N.V Internationaleiaan 55, 1070 Brussels, Belgium || Manufactured for/ Fabrique' pour: || Ansell Healthcare products LLC. || 1635 Industrial Road Dothan, AL 36303, USA || TEL USA- 1-800-952-9916 CAN- 1-844-494-7854 || catalog #20277285
  • Manufacturer
    Ansell Healthcare Products LLC

Manufacturer

Ansell Healthcare Products LLC
  • Dirección del fabricante
    Ansell Healthcare Products LLC, 111 Wood Ave S Ste 210, Iselin NJ 08830-2700
  • Empresa matriz del fabricante (2017)
    Ansell Ltd.
  • Source
    USFDA