Events

Recall of unkown device

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 N/A.

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
    2003-07-21
  • 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-de-sets-de-soins-du-laboratoire-pharmaset
  • 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
    Following the withdrawal of batches 438396B (expiry date 11/2006), 439362B (expiry date 12/2006) and 443510B (expiry date 09/2007) of ampoules of 20 ml sodium chloride 0.9% AGUETTANT on June 27, 2003 (due to the evidence of foreign particles in some ampoules), the PHARMASET SAS Laboratory withdraws from the market care sets containing these batches of ampoules .. The ampoules of sodium chloride contained in these sets are used to rinse or purge devices (catheters, pipes ...). Each recipient will be informed directly of the references and sets of sets (containing the lots of ampoules that have been withdrawn) that were sent to him. Approximately 30 lots of sets are involved at 74 customers.

Device

unkown device
  • Model / Serial
  • Product Description
    medical_device
  • Manufacturer
    N/A

Manufacturer

N/A
  • Source
    LAANSM