Events

Retiro De Equipo (Recall) de Device Recall Well at Walgreens Warm Steam Personal Steam Inhaler

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 Bigwall Enterprises.

¿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
    72837
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0698-2016
  • Fecha de inicio del evento
    2015-11-20
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2018-03-06
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=142338
  • 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
    Humidifier, non-direct patient interface (home-use) - Product Code KFZ
  • Causa
    "the public reason for the recall is that the product is being recalled out of an abundance of caution due to one or more consumer complaints, which have been independently investigated and remain unconfirmed. no causal connection between the complaints and the producta¿"s proper use as instructed have been determined.".
  • Acción
    The firm has only sold the product to Walgreens. Walgreens has notified all of its distribution centers and stores. According to the firm: "Walgreens has issued a stop sale at the store level. Units removed from store shelves and in stock will be sent back to the Walgreens distribution center Valparaiso, Indiana. As units are received from all store locations they will be sent to Bigwall Enterprises."

Device

Device Recall Well at Walgreens Warm Steam Personal Steam Inhaler
  • Modelo / Serial
    Model: PJ1011 Item: 366596 UPC code: 31191717008 Lot No. 08/14: 45228pcs Lot No. 12/14: 21096pcs Lot No. 01/15: 14220pcs Lot No. 03/15: 20040pcs
  • Clasificación del producto
    Anesthesiology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution including Washington, DC, U.S. Virgin Islands, and Puerto Rico.
  • Descripción del producto
    WARM STEAM Personal Steam Inhaler-Adjustable control to regulate flow of steam Soft touch facial & nasal masks" || Product labeling reads in part: "Well at Walgreens***WARM || Helps relieve symptoms of stuffy nasal passages, congestion or scratchy throats due to cold, flu or allergies
  • Manufacturer
    Bigwall Enterprises

Manufacturer

Bigwall Enterprises
  • Dirección del fabricante
    Bigwall Enterprises, 125 55th St Ste 200, Clarendon Hills IL 60514-6307
  • Empresa matriz del fabricante (2017)
    Bigwall Enterprises Inc.
  • Source
    USFDA