Events

Recall of Opafuseur SR LP

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
    2002-06-28
  • 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-du-dispositif-opafuseur-sr-lp-de-la-societe-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
    B. Braun Medical withdrew from the market on June 18, 02 lots 00K18821PD, 00K26821PD, 00L09821PB, 01D02821PC, 01G18821PB, 01I10821PC of the medical device called Opafuseur SR LP reference 86773R following a few cases of separation at the connection tubing - chamber at the time of handling the device .. The Opafuseur is a gravity infuser, opaque for photosensitive products.

Device

Opafuseur SR LP
  • Model / Serial
  • Product Description
    medical_device
  • Manufacturer
    B. Braun Medical

Manufacturer

B. Braun Medical
  • Source
    LAANSM