Events

Recall of Channel 8F steerable introducer sheath

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 BARD.

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
    2006-07-17
  • 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-lots-de-gaine-d-introduction-orientable-bard-channel-8f
  • 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 BARD company withdrew from the market on July 11, 2006 several batches of the medical device called "BARD Channel 8F orientable introducer sheath", reference XD10775003, following a complaint about an air suction at the hemostatic valve, due to the presence of small holes in the valve. The company has directly notified the recipients of the incriminated lots by means of the attached message (11/07/2006) (22 KB) validated by Afssaps. This information is addressed to the directors of health facilities and to the local correspondents for material vigilance for dissemination, where appropriate to the services concerned. The competent European authorities concerned shall be informed of this measure by the manufacturer.

Device

Channel 8F steerable introducer sheath
  • Model / Serial
  • Product Description
    medical_device
  • Manufacturer
    BARD

Manufacturer

BARD