Events

Retiro De Equipo (Recall) de Unshielded Biliary Endoprostheses (SHS)

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 LIFE PARTNERS EUROPE.

¿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
    2009-12-04
  • 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/rappel-de-lots-d-endoprotheses-biliaires-couvertes-shs-et-non-couvertes-shcl-par-life-parners-europe
  • 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 02/12/09, LIFE PARTNERS EUROPE removed from the market the batches of the references (listed in the mail destined for these customers) of medical devices called "Unshielded Biliary Endoprostheses (SHS)" and "Biliary Endoprostheses Covered with Lasso". -Hanarostent (SHCL) "following a defect that may occur during the placement of prostheses. Concerning the SHS reference, this is a blockage of the introducer of the stent and concerning the reference SHCL, it is a poor deployment of the prostheses at the level of the flare which carries the lasso: the Silicone blanket and lasso remain agglomerated. The company LIFE PARTNERS EUROPE has directly notified the recipients of the offending lots with the message attached (04/12/2009) (109 KB) validated by Afssaps. 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. Read also Additional information from 14/01/2010

Device

Unshielded Biliary Endoprostheses (SHS)

Manufacturer

LIFE PARTNERS EUROPE