Events

Recall of ALCO PREP LARGE;ALCO PREP MEDIUM

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 HOSPIDEX France (MSH group).

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
    2011-02-03
  • Event Country
    France
  • Event Source
    ANSM
  • Event Source URL
    https://ansm.sante.fr/S-informer/Informations-de-securite-Retraits-de-lots-et-de-produits/dispositifs-medicaux-alco-prep-hospidex-france-groupe-msh-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
    On 25 and 26/01/2011, the company HOSPIDEX France (MSH group) has withdrawn from the market all batches of the reference of the medical devices called ALCO PREP LARGE (ref 610) and ALCO PREP MEDIUM (ref. by TRIAD Group (USA) on behalf of H & W (B-3384 GLABBECK Belgium), following the discovery of contamination of these products by the bacterium Bacillus cereus Hospidex France (MSH Group) has directly notified the recipients of the incriminated batches by means of the enclosed message validated by Afssaps (03/02/2011) (1794 kb) This information is intended for directors and correspondents of materiovigilance for distribution if necessary The competent European authorities concerned are informed of this measure by the company H & W (Belgium) Read also Alcohol stamps and wipes of the company Triad Group: Potential contamination by a bacterium (03/02/2011) - Comm Alcoholic buffers in training kits for Kogenate - Bayer Health Administration (03/02/2011) - Safety Information. Alcoholic buffers in administration kits for injection of Extavia - Novartis Pharma (03/02/2011) - Safety information. Alco Prep alcoholic buffers in Lutrelef 3.2 mg administration kits, powder and solvent for solution for injection (03/02/2011) - Safety Information. Alco Prep Alcoholic Pads in ViraferonPeg and Introna Boxes (03/02/2011) - Safety Information. Alcohol swabs in injection kits of Stelara 45 mg - Janssen Cilag (03/02/2011) - Safety information

Device

ALCO PREP LARGE;ALCO PREP MEDIUM

Manufacturer

HOSPIDEX France (MSH group)
  • Source
    LAANSM