Events

OXYGEN BRASS REGULATORS PRECISION MEDICAL EASY DIAL: (1) MODEL 168704DLB, (2) MODEL 168708DB, (3) MODEL 168708DLB, (4) MODEL 168715DB, (5) MODEL 168715DLB, (6) MODEL 168725DB. LOTS / DATE CODES: (1 THROUGH 6) 0999 À 0401 BODY STAMPS NEAR METAL ENTRY 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 PRECISION MEDICAL 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
    58
  • 날짜
    2001-04-27
  • 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
    The boards of these regulators were modified to reduce weight. these modifications allowed a user, without wishing, to place the regulator in the nitrogen valve position. the manufacturer began removal by a letter sent on april 24, 2001.
  • 조치
    VERIFY THAT YOU HAVE RECEIVED THE PRECISION MEDICAL LETTER OF APRIL 24, 2001 .. IDENTIFY AND ISOLE ANY OF THESE PRODUCTS THAT ARE IN YOUR INVENTORY. PRECISION MEDICAL ENSURES THAT ALL PRODUCTS RETURNED WILL BE REPLACED FREE OF CHARGE. TO RECEIVE THE RETURN AUTHORIZATION FORM CONTACT THE REMOVAL COORDINATOR BY E-MAIL REGULATOR@PRECISIONMEDICAL.COM OR BY PHONE 0021-1-610-262-6090. PRECISION MEDICAL REQUESTS YOUR NAME, ADDRESS, PHONE NUMBER AND CONTACT NAME, AND THE NUMBER OF REGULATORS TO BE REPLACED IN ORDER TO ISSUE THE RETURN AUTHORIZATION NUMBER. FOR FURTHER INFORMATION CONTACT YOUR REPRESENTATIVE OR MEDICAL PRECISION BY PHONE 0021-1-610-262-6090.

Device

OXYGEN BRASS REGULATORS PRECISION MEDICAL EASY DIAL: (1) MODEL 168704DLB, (2) MODEL 168708DB, (3)...

Manufacturer

PRECISION MEDICAL INC
  • Source
    ANVSANVISA