Events

Recall of ProcedurePak Sterile Surgical Kits

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 Molnlycke Healthcare.

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
    2011-11-17
  • Event Country
    France
  • Event Source
    ANSM
  • Event Source URL
    https://ansm.sante.fr/S-informer/Informations-de-securite-Retraits-de-lots-et-de-produits/trousses-chirurgicales-steriles-procedurepak-molnlycke-healthcare-retrait-de-lots2
  • 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
    The Agency was informed of the implementation of a recall by Molnlycke Health Care. This recall is an extension of the recall of September 2011. The affected users have received the attached mail (17/11/2011) (23 KB). Read auss. ProcedurePak Sterile Surgical Kits - Molnlycke Healthcare - Batch Removal. (16/09/2011)

Device

ProcedurePak Sterile Surgical Kits

Manufacturer

Molnlycke Healthcare