Events

Recall of Arterial and venous femoral cannula lot removal with armature

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 Sorin Group Italia Srl.

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
    2007-10-02
  • Event Country
    France
  • Event Source
    ANSM
  • Event Source URL
    https://ansm.sante.fr/S-informer/Informations-de-securite-Retraits-de-lots-et-de-produits/retrait-de-lot-de-canules-femorales-arterielles-et-veineuses-en-polyurethane-avec-armature-societe-sorin-group-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 October 1, 2007, Sorin Group France withdrew from the market the batches of the references contained in the attached message of the medical device called veinous and arterial femoral cannulae made of polyurethane with reinforcement, including pediatric models, manufactured by Sorin Group Italia Srl, following an incident report mentioning the breakage of the tip of the introducer guide during the introduction of the cannula at the site of cannulation. The company Sorin Group France has directly notified the recipients of the incriminated lots with the message attached (02/10/2007) (34 KB) validated by Afssaps. The relevant European Competent Authorities are informed of this measure by the manufacturer.

Device

Arterial and venous femoral cannula lot removal with armature

Manufacturer

Sorin Group Italia Srl