Events

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

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 Politec Importação e Comércio Ltda; Sage Products Inc. 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

안전성 경고는 의료기기 제품과 관련된 중요한 정보와 권고사항을 담고 있습니다. 물론 안전성 경고가 배포되었다고 해서 해당 제품이 무조건 안전하지 않은 제품이라는 것은 아닙니다. 보건의료업계 종사자와 의료기기 사용자들에게 배포되는 안전성 경고에는 회수(recall)도 포함될 수 있습니다. 제조사가 안전성 경고를 작성하기도 하지만, 보건당국에서 작성하는 경우도 있습니다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Safety alert
  • 사례 ID
    1997
  • 날짜
    2016-08-30
  • 사례 국가
    Brazil
  • 사례 출처
    ANVISA
  • 사례 출처 URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • 비고 / 경고
    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.
  • 데이터 추가 비고
    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
  • 원인
    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.
  • 조치
    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