Events

Recall of Oxygen-deflected fittings on high pressure rail

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 CAHOUET.

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
    2003-07-11
  • Event Country
    France
  • Event Source
    ANSM
  • Event Source URL
    https://ansm.sante.fr/S-informer/Informations-de-securite-Retraits-de-lots-et-de-produits/alerte-relative-a-des-raccords-detrompes-oxygene-sur-rampe-haute-pression
  • 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
    It has recently been detected by AGA Medical's technical departments of cracking cases on oxygen-deflected fittings located on high pressure ramps of a gaseous medical oxygen distribution plant. The company CAHOUET, manufacturer of these fittings wishes to proceed with the recall of parts deemed potentially defective .. The ramps concerned are: CAHOUET reference / AGA Medical. Oxygen Ramp - 1 bottle VL2135 + RW1237 + JD2316 / R 61 23 8. Oxygen Wall Rail - 2 Bottles VL2231 + RW1237 + JD2316 / R 61 23 8. Oxygen Wall Rail - 3 Bottles VL2316 + RW1237 + JD2316 / R 61 23 8. The batch numbers are between No. 61259 and No. 64677 (fittings manufactured between 10/2001 and 10/2002). These connections must be replaced as soon as possible by authorized AGA Medical personnel. AGA Medical will contact the users of these devices directly.

Device

Oxygen-deflected fittings on high pressure rail
  • Model / Serial
  • Product Description
    medical_device
  • Manufacturer
    CAHOUET

Manufacturer

CAHOUET
  • Source
    LAANSM