Events

Retiro De Equipo (Recall) de Device Recall Ambitex NMD400 Nitrile Exam Gloves

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 Cardinal Health.

¿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
    72078
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0133-2016
  • Fecha de inicio del evento
    2015-08-25
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2016-08-01
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=140214
  • 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
    Polymer patient examination glove - Product Code LZA
  • Causa
    Ambitex nitrile nmd400 exam gloves size medium on exam hold were inadvertently placed into commerce. the product was under exam hold because samples pulled from a shipment manufactured by the firm failed the water leak test performed by fda as described at 21 cfr 800.20.
  • Acción
    The firm sent an Urgent: Product Recall letter dated 8/25/2015. The firm is requesting the user discontinue using and return any remaining stock of the AMBITEX Nitrile Exam Gloves because the gloves were inadvertently shipped prior to U.S. FDA releasing them for sale. Additionally, the firm requests that the customer quarantine the affected examination gloves; and return a copy of the enclosed Acknowledgment Form confirming their receipt of the Urgent recall via fax to 216-651-9760. Customer Service should be contacted at 800-GLOVES-0 to arrange for the return and credit of any on hand product that customer may have. If the customer has further distributed the affected gloves they are advised to notify their customers of the recall.

Device

Device Recall Ambitex NMD400 Nitrile Exam Gloves
  • Modelo / Serial
    Ambitex NMD400 Nitrile Exam Glove LOT NUMBER: 25314
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution.
  • Descripción del producto
    Ambitex NMD400 Nitrile Exam Gloves size medium. General Hospital and Personal use. || Intended to be worn on the hand for medical purposes to provide a barrier against potentially infectious materials and other contaminants.
  • Manufacturer
    Cardinal Health

Manufacturer

Cardinal Health
  • Dirección del fabricante
    Cardinal Health, 1300 Waukegan Rd, Waukegan IL 60085-6724
  • Empresa matriz del fabricante (2017)
    Cardinal Health
  • Source
    USFDA