Events

Retiro De Equipo (Recall) de Custom surgical packs for a variety of surgical applications. Each pack is custom assembled and contains a variety of components including blades, gowns, needles, sponges, towels, syringes, gloves, etc. || All products could have the WINDSTONE MEDICAL INC. label or the CARDIO-PAK label. || MAJOR PACK

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 Windstone Medical, 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
    25830
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0753-03
  • Fecha de inicio del evento
    2003-03-25
  • Fecha de publicación del evento
    2003-04-22
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2003-09-09
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=26554
  • 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 and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel data.
  • Notas adicionales en la data
  • Causa
    Product has latex free symbol on package, yet contains latex components.
  • Acción
    On 3/25/03 the firm contacted their customers by telephone. This was followed by a letter dated 3/25/03. Enclosed with the letter is a response form for the customer to fill out and return to the firm. Product is to be returned to the firm.

Device

Custom surgical packs for a variety of surgical applications. Each pack is custom assembled and ...
  • Modelo / Serial
    Catalog number 002117-000 Lot numbers 000006595, 000006895
  • Clasificación del producto
    Cardiovascular Devices
  • Distribución
    The firm distributed to 13 hospitals and medical facilities located in CO, IN, MI, MN, MT, UT, and WA.
  • Descripción del producto
    Custom surgical packs for a variety of surgical applications. Each pack is custom assembled and contains a variety of components including blades, gowns, needles, sponges, towels, syringes, gloves, etc. || All products could have the WINDSTONE MEDICAL INC. label or the CARDIO-PAK label. || MAJOR PACK
  • Manufacturer
    Windstone Medical, Inc.

Manufacturer

Windstone Medical, Inc.
  • Dirección del fabricante
    Windstone Medical, Inc., 1602 4th Ave North, Billings MT 59101
  • Source
    USFDA