LANCETAS SFL YELLOW 2.2X1.0mm - MICROTAINER BRAND SAFETY FLOW LANCETS BDLANCETA MICROTRAINER. II - MEDIUM RISK, Reg. ANVISA: 10033430270 - Lots: 2319394, 3069725, 3149410 and 3213535. 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 Becton Dickinson and Company 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
    896
  • 날짜
    2007-11-27
  • 사례 국가
  • 사례 출처
    ANVISA
  • 사례 출처 URL
  • 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
    Upon failure of the anti-reuse device, the lancet blade may be exposed during disposal. Note: manufacture of this product was discontinued in 2003. The last sale in Brazil occurred in 2004 and the registration of the product with ANVISA was valid until the year 2005. The product in question is not intended for home users, only hospitals and clinics According to the company there were no reported problems with the lots involved in Brazil and that the collection of this product 3 years after the closure of sales is preventive. For further information contact the BD Technical Center, through the Telephone. 0800.055.5654.// Update: On January 23, 2008 the company reported that 38 customers received the product and that all were informed of the recall, of which 24 stated they did not have any unit of the lots involved in stock. They also reported that this recall was released in the media (newspaper, radio and television) in November 2007.
  • 원인
    Limited number of reports of device-trigger device crash. access the lots: http://www.Anvisa.Gov.Br/tecnovigilancia/alertas/anexos_2007/896.Pdf.
  • 조치
    Voluntary pickup with mailing for all customers requesting that the use of the product be interrupted and the remaining quantities are returned to the company.

Manufacturer

  • Source
    ANVSANVISA