Events

Recall of Batches sterile drapes and instrument pouches with adhesive

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 CAREFUSION France.

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
    2009-12-30
  • 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-lots-des-dispositifs-medicaux-champs-operatoires-steriles-et-poches-a-instruments-avec-adhesif-par-carefusion-france
  • 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 29/12/09, the company CAREFUSION France 205 removed from the market batches 359340 to 366984 references of the following medical devices. - 951FRB and 951FRC: Operative field 50X65 cm with window. - WG29004A: Operative field 98X137 cm with window. - 96860FRB, 9686FRA, 96890FRB and 9689FRB: instrument pocket with adhesive. manufactured by CAREFUSION France, following the detection of a lack of integrity of the welds of the paper film sterilization bags. The company CareFusion France has directly notified the recipients of the incriminated lots with the message attached (30/12/2009) (46 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.

Device

Batches sterile drapes and instrument pouches with adhesive

Manufacturer

CAREFUSION France