Events

Recall of Medivac Range Sterile Tubing

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 Care Fusion.

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
    2010-09-21
  • Event Country
    France
  • Event Source
    ANSM
  • Event Source URL
    https://ansm.sante.fr/S-informer/Informations-de-securite-Retraits-de-lots-et-de-produits/tubulures-steriles-gamme-medivac-cardinal-health-care-fusion-extension-du-retrait-initial-du-06-09-2010
  • 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    On 20/09/2010, Care Fusion has withdrawn from the market the lots in Appendix 1, references NEX510, NEX56A, NEX610, NEX66A, NEX710, NEX712, NEX76A of the medical device called Sterile Tubing Range Medi-Vac, manufactured by Cardinal Health, following the identification of a potential welding defect concerning the packaging of the references in question. This withdrawal is an extension of a first withdrawal implemented on 06/09/201. .. The company Care Fusion has directly notified the recipients concerned with the message attached (21/09/2010) (40 KB) validated by Afssaps .. This information is intended for directors and correspondents of materiovigilance for dissemination where appropriate to the services concerned. The competent European authorities concerned shall be informed of this measure by the European representative.

Device

Medivac Range Sterile Tubing
  • Model / Serial
  • Product Description
    medical_device
  • Manufacturer
    Care Fusion

Manufacturer

Care Fusion