Events

Recall of Hemodialysis accessories reference S660C and C330 from the company GAMBRO

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.

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
    2003-02-10
  • 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-d-accessoires-pour-hemodialyse-reference-s660c-et-c330-de-la-societe-gambro
  • 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
    GAMBRO withdraws from the market batches 0241-40 and 0238-40 of the reference S660C (product code 6431233A) and batches 0239-40, 0242-40 and 0245-40 of the reference C330 (product code 6430086) of the medical devices called hemodialysis accessories due to a high rate of nonconformities, ie cracks or breaks in the female luer lock connector that can lead to leakage during use (the cases reported to date have not had any serious consequences Patients) .. The S660C is a dialysis accessory that allows the connection between the blood line and the fistula needle or catheter to perform a single needle treatment.The C330 is an extension line for recirculation of the priming solution in the blood lines.

Device

Hemodialysis accessories reference S660C and C330 from the company GAMBRO
  • Model / Serial
  • Product Description
    medical_device
  • Manufacturer
    GAMBRO

Manufacturer

GAMBRO
  • Source
    LAANSM