Events

Recall of KRATZ blepharostat and infusion cannulas from MCP

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 Micro Chir Provence (MCP).

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
    2003-06-27
  • 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-blepharostat-de-kratz-et-de-canules-d-infusion-de-la-societe-mcp
  • 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 Agency and following an inspection, the company Micro Chir Provence (MCP), withdraws from the market:. batch B30108 of the reference B31050 of the medical device called blepharostat of KRAT. batches B30201 and B30105 of reference B41060 - infusion cannulas. lot B30106 of reference B41061- infusion cannulas. batch B30107 of the reference B41064 - infusion cannulas following the absence of an EC certificate of conformity and the absence of validation of the sterilization. These devices are used in cataract surgery. These devices are distributed by PRODIS, which will directly inform the 4 users of these batches (France).

Device

KRATZ blepharostat and infusion cannulas from MCP

Manufacturer

Micro Chir Provence (MCP)
  • Source
    LAANSM