Events

Recall of EASYPUMP LT 100-48;EASYPUMP LT 60-24

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 B.Braun Medical.

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
    2008-08-22
  • Event Country
    France
  • Event Source
    ANSM
  • Event Source URL
    https://ansm.sante.fr/S-informer/Informations-de-securite-Retraits-de-lots-et-de-produits/rappel-de-lots-de-systeme-de-perfusion-easypump-lt-100-48-et-lt-60-24-b-braun-medical
  • 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    On 20/08/2008, the company B.Braun Medical has withdrawn from the market the batches and references mentioned in the recall of the medical devices called: EASYPUMP LT 100-48 and EASYPUMP LT 60-24, the syringes are manufactured by B. Braun Melsungen AG, Switzerland and Easypump infusion sets by I-Flow Corporation in the USA. This withdrawal follows the discovery during a routine inspection of products from the production sample library. perforations of certain syringe packages that may compromise the sterility of the medical device. The company B.Braun medical has directly notified the recipients of the incriminated lots with the message attached (22/08/2008) (193 KB) validated by Afssaps. This information is addressed to the directors and correspondents of materiovigilance for diffusion if necessary to the services concerned.

Device

EASYPUMP LT 100-48;EASYPUMP LT 60-24
  • Model / Serial
  • Product Description
    medical_device
  • Manufacturer
    B.Braun Medical

Manufacturer

B.Braun Medical