Events

Retiro De Equipo (Recall) de Weck brand ligature clips for Hem-o-lok, Horizon, Hemoclip Traditional products and Hemoclip Plus

Según L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en France que fue producido por Teleflexmedical.

¿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
  • Fecha
    2008-09-26
  • País del evento
    France
  • Fuente del evento
    ANSM
  • URL de la fuente del evento
    https://ansm.sante.fr/S-informer/Informations-de-securite-Retraits-de-lots-et-de-produits/retrait-de-lots-de-clips-de-ligatures-non-absorbables-teleflex-medical-weck-clips-horizon-hemoclip-plus-hemoclip-et-hemo-o-lock-la-societe-teleflexmedical
  • Notas / Alertas
    French data is current through early September 2018. All of the data comes from L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), except for the categories Manufacturer Parent Company and Product Classification.
    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, based on matches of recall data from the U.S. and France.
  • Notas adicionales en la data
  • Acción
    On 16/09/2008, the company Teleflexmedical removed from the market the batches listed in the appendix of the recall, the medical device: Weck brand ligature clips for Hem-o-lok, Horizon, Hemoclip Traditional products and Hemoclip Plus manufactured by Teleflex Medical, following claims in the United States reporting visible quality defects (lack of unit packaging of clip bars) that could compromise the sterility of the product. The company Teleflexmedical has directly notified the recipients of the incriminated lots with the message attached (26/09/2008) (97 KB). This information is addressed to the directors and correspondents of materiovigilance for diffusion if necessary to the services concerned. The relevant European Competent Authorities are informed of this measure by the manufacturer.

Device

Weck brand ligature clips for Hem-o-lok, Horizon, Hemoclip Traditional products and Hemoclip Plus
  • Modelo / Serial
  • Descripción del producto
    medical_device
  • Manufacturer
    Teleflexmedical

Manufacturer

Teleflexmedical