Events

Recall of Y connector (dialysis accessory)

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 Gambro Hospal.

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
    2010-10-25
  • Event Country
    France
  • Event Source
    ANSM
  • Event Source URL
    https://ansm.sante.fr/S-informer/Informations-de-securite-Retraits-de-lots-et-de-produits/connecteur-y-accessoire-de-dialyse-gambro-hospal-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 October 21, 2010, the company Gambro Hospal removed from the market batches 1035 and 1037 of the reference 6431233 of the medical device called "dialysis accessory: connector YS 660 C", manufactured by Gambro Dasco, following the highlighting internally the possible presence of a micro-hole at the female luer fitting that could possibly result in the penetration of air into the blood. No reports have been reported to date. The company GAMBRO HOSPAL directly warned the recipients of the incriminated lots with the message attached (25/10/2010) (1319 kb) validated by Afssaps. This information is intended for directors and correspondents of materiovigilance for dissemination where appropriate to the services concerned. The relevant European Competent Authorities are informed of this measure by the manufacturer.

Device

Y connector (dialysis accessory)
  • Model / Serial
  • Product Description
    medical_device
  • Manufacturer
    Gambro Hospal

Manufacturer

Gambro Hospal