Events

(1) A-11, (2) A-15, (3) A (1) A-11, (2) A-15, (3) A -18, (4) A-22, (5) AF-150, (6) AF-180, (7) AF-220, (8) AX-15, (9) AX-22; dialyzer with cellulose acetate fiber series A: (10) Altra Flux, (11) Altra Nova, (12) Altrex, Product codes: (1) 237011, 237311, 237511; (2) 237015, 237315, 237515; (3) 237018, 237318, 237518; (4) 237022; (5) 238015, 238515; (6) 238018, 238518; (7) 238022, 238522; (8) 239015; (9) 239022, 239522; (10 to 12) unidentified; number of lots: (1 to 9) all numbers, (10) 990904P6A1 to 011017P7A, (11) 990924P1D1 to 011019P4A, (12) 990929P6A1 to 000203P6A1; number of catalogs: (1 to 9) unidentified; (10 to 12) 100-416, 100-923, 700-098, 700-150 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 Baxter International 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
    385
  • 날짜
    2001-12-07
  • 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
    UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
  • 원인
    Ecri discussed the current baxter dialysis research on deaths in the united states and abroad. the fda recently issued additional information regarding this correction. in addition to the original models being corrected, baxter is withdrawing its a-11, ax-15 and ax-22 models as a precautionary measure, baxter is redoing the altra flux series a cellulose acetate , altra nova and altrex used in baxter a, af and ax series dialyzers.
  • 조치
    Please verify receipt of the dated letter and response form dated October 18, 2001 from Baxter. Identify and isolate all affected products in your inventory. Baxter recommends that you immediately stop using any of the products mentioned above. Complete and return the response form to the following fax number (847) 270-5457. If you have distributed these dialyzers to other establishments, please send the correction letter and the response form to these units immediately. For more information, contact your local representative and visit http://www.baxter.com/customers/cust_svc/index.html to find links specific to your country. Baxter began corrections by telephone and by letter dated October 18, 2001.

Device

(1) A-11, (2) A-15, (3) A (1) A-11, (2) A-15, (3) A -18, (4) A-22, (5) AF-150, (6) AF-180, (7) AF...

Manufacturer

Baxter International Inc
  • Source
    ANVSANVISA