Events

Safety Alert for Trade name: Antiseptic Towels Technical Name: Assepsis Handkerchief in Medical Procedures ANVISA Registration Number: 10178010150 Hazard Class: I Affected Model: CODE 9602-X

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Politec Importação e Comércio Ltda; Sage Products Inc..

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Event ID
    1997
  • Date
    2016-08-30
  • Event Country
    Brazil
  • Event Source
    ANVISA
  • Event Source URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alerts
    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.
  • Extra notes in the data
    Do not use or distribute products involved in this recall. Return the product to your supplier / distributor so that the correct treatment is carried out (destruction of the material or return to the manufacturer - awaiting decision). 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. If you wish to notify technical complaints and adverse events use the following channels: Notivisa: Notices of adverse events (AE) and technical complaints (QT) for products subject to Sanitary Surveillance should be made through the NOTIVISA System. To access the System, you must register and select the Health Professional option, if you are a liberal professional or the Institution / Entity option, if you are a professional of an institution / entity. Technovigilance System: Patient or citizen can notify through the Technovigilance System / SISTEC access through the link
  • Reason
    Potential contamination of certain lots of the product by the bacterium burkholderia cepacia. according to sage products inc., topical administration of the potentially contaminated product may, under certain circumstances, cause infections in immunocompromised users and inpatients, as well as in other patient groups.
  • Action
    Action of Field nº 142/16 triggered under the responsibility of the company Politec Importação e Comércio LTDA. Classification of risk: II Classification of the field action: Recollection; Undoing. Direct communication through letter, email and / or telephone to customers and / or distributors for voluntary recall notice. In case client / distributor still have units in stock, such units should return to Politec Saúde for correct final disposal. 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.

Device

Trade name: Antiseptic Towels Technical Name: Assepsis Handkerchief in Medical Procedures ANVISA ...

Manufacturer

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