Events

Recall of Medi-Vac 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
    2010-09-08
  • 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-retrait-de-lots
  • 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    On 06/09/10, the company Care Fusion has withdrawn from the market all the batches not included pa. in the list in Appendix 1, references NEX510, NEX56A, NEX66A, NEX710, NEX712, NEX76A of the medical device called Medi-Vac Range Sterile Tubing, manufactured by Cardinal Health, following the identification of a potential defect in sold on the packaging of the subject references, delivered in the period from 2 January 2007 to 23 August 2010. Care Fusion directly notified the recipients concerned with the enclosed message (08/09/2010) (60 ko) validated by the Afssaps. This information is addressed to the directors and correspondents of materiovigilance for diffusion if necessary to the services concerned. The competent European authorities concerned shall be informed of this measure by the European representative. Read auss. Expansion of Initial Removal - Sterile Tubing Medivac Range, Cardinal Health - Care Fusio. (21/09/2010)

Device

Medi-Vac Range Sterile Tubing
  • Model / Serial
  • Product Description
    medical_device
  • Manufacturer
    Care Fusion

Manufacturer

Care Fusion