Events

Alerte De Sécurité sur CATERING REINTRODUCTION OUTBACK LTD. All Lots. Catalog Number: OTB42120. Anvisa Reg: 80145900965.

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 Cordis Corporation.

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
    938
  • Date
    2008-09-02
  • 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
    The manufacturer of the product (Cordis Corporation) has verified that the rate of separation of the cannula of the application slider, in the assembly of the handle in the Catheter of Reintroduction Outback LTD, is larger than the expected one. The potential result of this separation is the impossibility of retracting the cannula needle into the cannula body. The manufacturer has concluded that it will be necessary to carry out a voluntary recall of all batches of the product (code OTB42120) that are on the market. According to a letter of clarification sent by Johnson & Johnson Medical Brasil Ltda to the Anvisa Tecnovigilance Unit (UTVIG), the collection applies to all batches of the product.
  • Cause
    Potential for failure of the reintroduction cannula by retracting into the catheter.
  • Action
    The actions requested of the user are as follows: (1) Locate, separate and identify immediately all affected products to ensure that they are not used; (2) Complete and return the Recall Confirmation Form to the product registration holder (Johnson & Johnson Medical Brazil Ltda.); (3) Return the products at risk to the record holder, either directly or through local sales representatives; (4) If any product has been shipped to another establishment, please contact us to arrange for the return of the product.

Device

CATERING REINTRODUCTION OUTBACK LTD. All Lots. Catalog Number: OTB42120. Anvisa Reg: 80145900965.

Manufacturer

Cordis Corporation