Events

Retiro De Equipo (Recall) de Skater® (7565 and 7560 series) and TCD Choice Lock (7160 and 7165) Direct Drainage Drains

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 Angiotech-PBN MEDICALS Denmark A / S.

¿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
    2009-09-21
  • 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-tous-les-lots-des-dispositifs-medicaux-sets-de-drainage-en-ponction-directe-skater-r-gammes-7565-et-7560-et-tcd-choice-lock-gammes-7160-et-7165-fabriques-par-pbn-medicals-denmark-a-s
  • 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    On 16/09/2009, the company Angiotech-PBN MEDICALS Denmark A / S has withdrawn from the market all the batches of the references listed in the annex (21/09/2009) (44 ko) of the recall letter of the medical devices called: sets Skater® (7565 and 7560 series) and TCD Choice Lock (7160 and 7165) Direct Drainage Drains, manufactured by PBN MEDICALS Denmark A / S, as a result of claims received abroad for damaged secondary packaging. Indeed, the laboratory determined that the sterility integrity of the products distributed between September 2004 and September 2009 could be compromised. The loss of sterility presents an infectious risk. Angiotech-PBN MEDICALS Denmark A / S has directly notified the recipients of the offending batches with the attached message (21/09/2009) (91 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 have been informed of this measure by the manufacturer.

Device

Skater® (7565 and 7560 series) and TCD Choice Lock (7160 and 7165) Direct Drainage Drains

Manufacturer

Angiotech-PBN MEDICALS Denmark A / S
  • Source
    LAANSM