Events

Alerte De Sécurité sur SHIELD PROTECTIVE BARRIER SHIELD; 10178019031; Risk class I; Affected model (s): 7905-X 8 wipes; Lot (s) / Serial number (s) affected: 45602 - 11,040 units, 47086 - 7200 units, 47656 - 19.008 units, 48872 - 6.528 units.

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 Politec Importação e Comércio Ltd; Sage Products Inc..

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
    1996
  • Date
    2016-08-30
  • 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
    In this way, Politec Importação e Comércio Ltda., Will arrange the voluntary collection of this product, fulfilling us contact V. Sa. in order to inform about this recall and the temporary suspension of product supply. The subject of this recall includes different lot numbers as indicated in the table below, noting that batches received by V. Sa. are the ones mentioned in the body of the email. In view of this recall and given the procedures stipulated by regulatory agencies, among other provisions also applied, we require that you. take the following measures: 1) Cease the use and distribution of batches of listed products 2) Complete the attached acknowledgment report, sign it and send it immediately to recallsage@politecsaude.com.br. This will allow confirmation of receipt of this notification and also confirmation of the quantity of this product in your hands. 3) If you have in stock for resale, consumption or any other purpose any batches of the product subject to such recall segregate it. The form of compensation through credit or exchange will be informed in a timely manner. 4) As a distributor or reseller of our products, we require you to inform us who has or has shipped the product on screen. Please use the enclosed worksheet. Politec Importacao e Comércio Ltda., Is taking all applicable measures to avoid any inconvenience that may arise from this recall voluntarily initiated by Sage Products Inc .. For any information or clarification on this subject, Milena Raizer (recallsage@politecsaude.com.br) or by phone 11 - 99690-4626.
  • Cause
    Potential contamination of certain batches of the product by the bacterium burkholderia cepacia./// according to sage products inc., topical administration of the possibly contaminated product may, under certain circumstances, cause infections in immunocompromised users and hospitalized patients, as well as in groups of patients.
  • Action
    Field Action No. 141/16 triggered under the responsibility of the company Politec Importação e Comércio LTDA. Classification of risk: II Classification of the field action: Recollection; Return to the manufacturer. Politec Importação e Comércio Ltda., Will arrange the voluntary collection of this product, fulfilling us contact V. Sa. in order to inform about this recall and the temporary suspension of product supply. The subject of this recall includes different lot numbers as indicated in the table below, noting that batches received by V. Sa. are the ones mentioned in the body of the email. In view of this recall and given the procedures stipulated by regulatory agencies, among other provisions also applied, we require that you. take the following measures: 1) Cease the use and distribution of batches of listed products 2) Complete the attached acknowledgment report, sign it and send it immediately to recallsage@politecsaude.com.br. This will allow confirmation of receipt of this notification and also confirmation of the quantity of this product in your hands. 3) If you have in stock for resale, consumption or any other purpose any batches of the product subject to such recall segregate it. The form of compensation through credit or exchange will be informed in a timely manner. 4) As a distributor or reseller of our products, we require you to inform us who has or has shipped the product on screen. Please use the enclosed worksheet. Politec Importacao e Comércio Ltda., Is taking all applicable measures to avoid any inconvenience that may arise from this recall voluntarily initiated by Sage Products Inc .. For any information or clarification on this subject, Milena Raizer (recallsage@politecsaude.com.br) or by phone 11 - 99690-4626.

Device

SHIELD PROTECTIVE BARRIER SHIELD; 10178019031; Risk class I; Affected model (s): 7905-X 8 wipes; ...

Manufacturer

Politec Importação e Comércio Ltd; Sage Products Inc.
  • Source
    ANVSANVISA