Events

Recall of BBL GasPak Pouch System;BBL GasPak CamyPouch System

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 BD Diagnostics.

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
    2005-12-07
  • 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-des-dmdiv-bbl-gaspak-pouch-system-bbl-gaspak-camypouch-system-bd-diagnostic
  • 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 December 5, 2005, BD Diagnostics removed from the market the batches listed in the attached message, in vitro diagnostic medical devices called BBL GasPak Pouch System reference 260651 and BBL GasPak CamyPouch System reference 260656. devices are pocket systems generating either an atmosphere adapted to the culture of anaerobic bacteria, or an atmosphere adapted to the culture of microaerophilic bacteria. This decision follows the detection of a bacterial contamination of the liquid reagent sachets contained in the aforementioned systems .. The company has directly notified the recipients of the offending lots by means of the message attached (05/12/2005) (69 KB) validated by Afssaps. The competent European authorities concerned are informed directly by the manufacturer. This information is intended for laboratory managers, the directors of health establishments and the reactovigilance correspondents for dissemination, where appropriate, to the services concerned.

Device

BBL GasPak Pouch System;BBL GasPak CamyPouch System
  • Model / Serial
  • Product Description
    in-vitro_medical_device
  • Manufacturer
    BD Diagnostics

Manufacturer

BD Diagnostics