Events

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. 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 Politec Importação e Comércio Ltd; 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
    1996
  • 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
    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.
  • 원인
    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.
  • 조치
    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