Events

Recall of Device Vacuum Safety Direct SV 33

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 AGA MEDICAL.

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
    2007-03-02
  • Event Country
    France
  • Event Source
    ANSM
  • Event Source URL
    https://ansm.sante.fr/S-informer/Informations-de-securite-Retraits-de-lots-et-de-produits/rappel-de-lots-de-dispositif-securite-de-vide-direct-sv-33-aga-medical
  • 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 28/02/07, AGA MEDICAL proceeded with the recall of lots 2060114 (manufactured on 06/01/06), 2060472 (manufactured on 27/01/06), 2060473 (manufactured on 27/01/06), 2061261 (manufactured on March 14, 2006), 2064111 (manufactured on September 25, 2006) of the medical device called "Direct Vacuum Safety Device SV 33, P / N R311044", due to a risk of blockage of the vacuum system. suction by the safety ball component of the anti-overflow system. The company has directly notified the recipients of the incriminated lots with the message attached (28/02/2007) (52 KB) validated by Afssaps. This information is addressed to the directors of health establishments and local correspondents of materiovigilance for dissemination where appropriate to the services concerned.

Device

Device Vacuum Safety Direct SV 33
  • Model / Serial
  • Product Description
    medical_device
  • Manufacturer
    AGA MEDICAL

Manufacturer

AGA MEDICAL
  • Manufacturer Parent Company (2017)
    Abbott Laboratories
  • Manufacturer comment
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    LAANSM