Events

Alerte De Sécurité sur GUIDE TO TEFLONATE ANGIOPLASTY 0.035 "X 150 CM JET BIOMETRIX, Model HR-3823. ANVISA Registration No. 10332200028. Lot under risk: I8119.

Selon Agência Nacional de Vigilância Sanitária (ANVISA), ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Brazil qui a été fabriqué par BIOMETRIX LTD (ISRAEL).; EPTCA Medical Devices Ltda..

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • ID de l'événement
    1335
  • Date
    2013-12-11
  • Pays de l'événement
    Brazil
  • Source de l'événement
    ANVISA
  • URL de la source de l'événement
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alertes
    Brazilian data is current through June 2018. All of the data comes from Anvisa, 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 data from the U.S. and Brazil.
  • Notes supplémentaires dans les données
    According to information presented by EPTCA Ltda, packaging was evidenced without the heat seal, which exposes the product to the environment and, consequently, compromises its sterility.
  • Cause
    Possible absence of heat seal in the primary packaging of the product, leading to the loss of the guarantee of its sterilization.
  • Action
    The product is being collected by the registration holder in Brazil. Identify in your stock and in the stocks of your customers (in the case of distributors) products under risk, verifying the integrity of the packaging sealing of all units of the product in question. Once defective products have been identified, segregate them to avoid inadvertent use. Please contact the record holder or your distributors for return purposes.

Device

GUIDE TO TEFLONATE ANGIOPLASTY 0.035 "X 150 CM JET BIOMETRIX, Model HR-3823. ANVISA Registration ...

Manufacturer

BIOMETRIX LTD (ISRAEL).; EPTCA Medical Devices Ltda.
  • Source
    ANVSANVISA