Retiro De Equipo (Recall) de Device Recall BagEasy Resuscitatior

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 Westmed 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
    56162
  • Clase de Riesgo del Evento
    Class 1
  • Número del evento
    Z-2332-2010
  • Fecha de inicio del evento
    2010-06-22
  • Fecha de publicación del evento
    2010-09-08
  • Estado del evento
    Terminated
  • País del evento
  • Fecha de finalización del evento
    2011-03-22
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
  • 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
    Ventilator, emergency, manual (resuscitator) - Product Code BTM
  • Causa
    This recall was initiated after westmed, inc. became aware of a potential for disconnection at the patient port retention ring assembly of the bag easy manual resuscitation device.
  • Acción
    The firm, Westmed, sent a letter dated June 21, 2010, to all customers. The letter describes the product, problem and action to be taken by customer. The customers were instructed to cease distribution immediately, notify any facilities that they may have distributed the product identified of the recall, call Customer Service Manager at 1-800-975-7987 x 1223 and/or email kpeterson@westmedinc.com to receive Return Authorization to return identified product, and complete and return the enclosed Bag Easy Recall Reconciliation Checklist. If you have any question, contact Customer Service at 1-800-975-7987 or 1-520-294-7987.

Device

  • Modelo / Serial
    510K # for Adult product: K934310  Part Number: 562013: Lot #47952, 48174, 48320, 48489, 48718, 48893, 49093, 49179, 49353, 49567, 49685  Part Number: 562048: Lot#47772, 47896, 47971, 47972, 48319, 48449, 48577, 48892, 48970, 49092, 49178  Part Number: 562133: Lot# 48321, 49225 49407  Part Number: 562136: Lot#47728, 49094 49275
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution.
  • Descripción del producto
    BagEasy manual resuscitation devices are used for patients requiring complete or intermittent ventilatory support. It can provide positive pressure ventilation or oxygen for the spontaneously breathing patient with a face mask or through an artificial airway. || A manual emergency ventilator is a device, incorporating a bag and valve, intended to provide emergency respiratory support by means of a face mask or a tube inserted into a patient's airway.
  • Manufacturer

Manufacturer

  • Dirección del fabricante
    Westmed Inc, 5580 South Nogales Hwy Ste 170, Tucson AZ 85706
  • Empresa matriz del fabricante (2017)
  • Source
    USFDA