Retiro De Equipo (Recall) de Device Recall Teleflex MEDICAL WECK Visistat 35

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 Teleflex Medical.

¿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
  • ID del evento
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
  • Fecha de inicio del evento
  • Estado del evento
    Open, Classified
  • País del evento
  • Fuente del evento
  • URL de la fuente del evento
  • 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
    Staple, removable (skin) - Product Code GDT
  • Causa
    Some boxes are labeled as visistat wide devices, when in fact the contain visistat regular devices. the 6 individually packaged units within the boxes are correctly labeled.
  • Acción
    The firm initiated the recall on 02/14/2018 by letter and followed up with another letter on 03/12/2018 to clarify the labeling issue. The letter to the distributor stated: "1. Immediately discontinue distribution and quarantine any products with the catalog and lot number listed above. 2. Inspect affected products within your control to identify if the box label correctly identifies the products inside the box. Products with an incorrect label on the box should be returned to Teleflex Medical so that they are not distributed to health care providers in error. 3. Using the provided Customer Letter and Acknowledgement Form templates, communicate this recall to any of your customers who have received product included within the scope of the recall. Customers may return mislabeled products if they choose to do so. Note the attached Customer Letter template was updated since this letter was first sent to you. 4. If any of your customers wish to return affected products, have them return the affected products to you, together with a completed Acknowledgement Form, for consolidation and return to Teleflex Medical. In the event that an alternative approach is needed, contact Teleflex Customer Service for more information at 1-866-246-6990." The customer letter requested discontinuation of use and quarantining of products and return of affected stock.


  • Modelo / Serial
    Lot Number 73H1600207
  • Clasificación del producto
  • Clase de dispositivo
  • ¿Implante?
  • Distribución
  • Descripción del producto
    Teleflex MEDICAL WECK Visistat 35. Used for the external skin closure of lacerations.
  • Manufacturer


  • Dirección del fabricante
    Teleflex Medical, 2917 Weck Dr, Research Triangle Park NC 27709-0186
  • Empresa matriz del fabricante (2017)
  • Source