Events

Retiro De Equipo (Recall) de TransTissue Filtron

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 Shippert Medical Technologies.

¿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
    78392
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0170-2018
  • Fecha de inicio del evento
    2017-10-20
  • Estado del evento
    Open, Classified
  • País del evento
    United States
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=159400
  • 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
    System, suction, lipoplasty - Product Code MUU
  • Causa
    Potential breach of sterility of the packaging.
  • Acción
    A n Urgent: Medical Device Recall letter, dated October 20, 2017, was mailed to the user, identifying the affected device and describing the reason for the recall. The letter also provided the risk to health involved and discussed how the user can recognize the failure. Customers were instructed to remove all affected product from their inventory and quarantine them. Additionally, the letter should be forwarded to all necessary staff. Customers are to complete the Recall Response letter within 10 calendar days. Only the affected products listed should be returned per the instructions provided. Questions should be directed to Customer Service at 800-888-8663.

Device

TransTissue Filtron
  • Modelo / Serial
    Lot 12004
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution -- United States, Australia, and Netherlands.
  • Descripción del producto
    Tissu-Trans Filtron 1000 Catalog Number 3-TT-FILTRON 1000. || Used for fat transfer and liposuction.
  • Manufacturer
    Shippert Medical Technologies

Manufacturer

Shippert Medical Technologies
  • Dirección del fabricante
    Shippert Medical Technologies, 6248 S Troy Cir Ste A, Centennial CO 80111-6485
  • Empresa matriz del fabricante (2017)
    Shippert Medical Technologies Inc
  • Source
    USFDA