Events

Recall of Specialties range Physiologica, 0.9% sodium chloride, Lyomer and saline

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 Gifrer Barbezat.

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
    2013-04-26
  • Event Country
    France
  • Event Source
    ANSM
  • Event Source URL
    https://ansm.sante.fr/S-informer/Informations-de-securite-Retraits-de-lots-et-de-produits/specialites-des-gammes-physiologica-chlorure-de-sodium-0-9-lyomer-et-serum-physiologique-gifrer-barbezat-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
    At the request of the ANSM, Gifrer Barbezat laboratories proceed, as a precautionary measure, to the recall, to their places of distribution, of certain batches of the medical devices listed below. This recall follows the detection of regulatory nonconformities in the manufacture of these medical devices that can not guarantee the quality of these products. The products concerned by this recall are. Physiologica Small child physiological serum 20 single dose / 5 m. Physiologica Small child physiological serum 40 single dose / 5 m. Physiologica Small child physiological serum 60 single dose / 5 m. Sodium Chloride 0.9% 30 vials / 100 m. Sodium Chloride 0.9% 30 vials / 45 m. Lyomer infant nasal spray solution 100 m. Lyomer plus nasal spray solution 100 m. Lyomer plus nasal spray solution 40 m. Lyomer nasal solution spray 100 m. SeptiLyomer nasal spray solution 40m. Physiological serum plus pharmacy 30 single doses / 5 m. Viaref physiological serum 30 single doses / 5 m. Physiologica dermactive 60 single doses / 5 m. Read auss. Decision of 22/04/2013 suspending the manufacture, placing on the market, export and distribution of medical devices, listed in the appendix, placed on the market by the company GIFRER BARBEZAT and the company LBD and withdrawing certain lots of these products. Courrier des laboratoires Gifrer Barbezat informing the batch recall (26/04/2013) (65 ko)

Device

Specialties range Physiologica, 0.9% sodium chloride, Lyomer and saline
  • Model / Serial
  • Product Description
    medical_device
  • Manufacturer
    Gifrer Barbezat

Manufacturer

Gifrer Barbezat
  • Source
    LAANSM