Events

Retiro De Equipo (Recall) de Device Recall Bath Safe Adjustable Shower Seat With Arms

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 Nutech Manufacturing Corp.

¿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
    53161
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0460-2010
  • Fecha de inicio del evento
    2009-07-09
  • Fecha de publicación del evento
    2009-12-01
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-05-29
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=85903
  • 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
    Transfer Aid - Product Code IKX
  • Causa
    Safety chair used in shower/bath may not meet specifications for weight load.
  • Acción
    The subsidiary distributor, Maddak, Inc. notified customers by A "Voluntary Product Recall Notice", phone and e-mail on 07/09/2009. The own label distributor instructed customers to return their inventory of affected products received between May 1, 2009 and July 7, 2009. Distributors were instructed to immediately quarantine then return all affected inventory to Maddak and notify their accounts. Distributors were requested to instruct dealers to display a "storefront" notice and provide consumers with a customer response form. Distributors were also requested to forward a request to dealers to post a website notice if they have one. Recovered products will be replaced.

Device

Device Recall Bath Safe Adjustable Shower Seat With Arms
  • Modelo / Serial
    Device is not identified with a lot code. Inventories received between May 1, 2009 and July 7, 2009 are being recalled.
  • Clasificación del producto
    Physical Medicine Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution -- USA and Canada.
  • Descripción del producto
    Bath Safe Adjustable Shower Seat, With Arms, Model numbers 727142020, 727142021, and MDS89750R
  • Manufacturer
    Nutech Manufacturing Corp

Manufacturer

Nutech Manufacturing Corp
  • Dirección del fabricante
    Nutech Manufacturing Corp, 2024 Broad Street, PO Box 840, Pocomoke City MD 21851-0840
  • Source
    USFDA