Events

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

According to L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), this recall involved a device in France that was produced by Angiotech-PBN MEDICALS Denmark A / S.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Date
    2009-09-21
  • Event Country
    France
  • Event Source
    ANSM
  • Event Source URL
    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
  • Notes / Alerts
    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.
  • Extra notes in the data
  • Action
    On 16/09/2009, the company Angiotech-PBN MEDICALS Denmark A / S has withdrawn from the market all the batches of the references listed in the annex (21/09/2009) (44 ko) of the recall letter of the medical devices called: sets Skater®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