Events

Recall of Angiography Catheters and Other Beacon Tip Tips

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 COOK INCORPORATED.

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
  • Event ID
    201509315
  • Date
    2016-05-02
  • Event Country
    France
  • Event Source
    ANSM
  • Event Source URL
    https://ansm.sante.fr/S-informer/Informations-de-securite-Retraits-de-lots-et-de-produits/catheters-d-angiographie-et-autres-dispositifs-a-embouts-beacon-tip-societe-cook-incorporated-retrait-de-produits
  • 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
    The ANSM has been informed of the implementation of a withdrawal of products by the company COOK INCORPORATED .. The users concerned have received the attached mail (02/05/2016) (350 KB). This security action is registered with the ANSM under the number 201509315, and follows two previous security actions, in July 2015 and November 2015. Read more. Interventional Cardiology - Torcon NB Advantage Beacon Tip, Royal Flush Plus Beacon Tip and Slip-Cath Beacon Tip Angiography Catheters - Cook lncorporated (20/07/2015) - Recall of batches. Angiography Catheters (04/11/2015) - Cook lncorporated - Batch Recall

Device

Angiography Catheters and Other Beacon Tip Tips

Manufacturer

COOK INCORPORATED