Events

Retiro De Equipo (Recall) de Device Recall Blue Belt Technologies

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 Blue Belt Technologies MN.

¿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
    65834
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1995-2013
  • Fecha de inicio del evento
    2013-07-19
  • Fecha de publicación del evento
    2013-08-21
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-11-14
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=120387
  • 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
    Drape, surgical - Product Code KKX
  • Causa
    Blue belt technologies is recalling sterile monitor drapes used with their navio pfs system during orthopedic knee surgery. the drapes are used to cover the navio pfs system computer monitor and arm assembly and provide a sterile barrier in the surgical suite. the defect is evident when the computer monitor is being draped. the front section of the drape separates from the rest of the drape at.
  • Acción
    Blue Belt Technologies contacted consignees by telephone using a script on July 19, 2013. The consignees were informed of the problem and the product involved in the recall. Consignees were advised to immediate stop using the product and to locate and quarantine all unused product. Additionally, an "Urgent Medical Device Recall" letter dated July 24, 2013 was issued on July 24, 2013 and August 12, 2013. The letter includes the description of the Issue, description of safety concerns, affected product, and action to be taken by user. For questions contact Blue Belt Technologies, Lindsey Bring (+1 763.452.4922) or Robin Gonzalez (+1 763.452.4910) and get a Return Authorization number. Lindsey or Robin will arrange a pickup of the product. BBT will send replacement product at no charge.

Device

Device Recall Blue Belt Technologies
  • Modelo / Serial
    Lot: D130432, expires February 2018
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution and US Nationwide in the states of: CA and PA. United Kingdom.
  • Descripción del producto
    Blue Belt Technologies, Inc. Monitor Drape REF: PFSD-V0001, Rx only, Sterile EO. || Product Usage: The intended use of this device is t protect equipment from contamination during a variety of procedures throughout the clinical setting.
  • Manufacturer
    Blue Belt Technologies MN

Manufacturer

Blue Belt Technologies MN
  • Dirección del fabricante
    Blue Belt Technologies MN, 2905 Northwest Blvd Ste 40, Plymouth MN 55441-2673
  • Source
    USFDA