Events

Rusch Belly Bag urine collection bag with hip belt 를 위한 안전성 경고 / 현장 안전성 서한

Medicines and Healthcare products Regulatory Agency에 따르면, 해당 안전성 경고 / 현장 안전성 서한 는 United Kingdom 에서 Teleflex Medical 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

현장 안전성 서한은 의료기기 제조사 또는 제조사 대리인이 시중에 유통되고 있는 자사 의료기기 제품에 대하여 취할 수 있는 조치를 알리는 소통방식입니다. 주요 대상층은 보건의료업계 종사자와 의료기기 사용자들입니다. 여기에는 회수(recall) 조치와 경고도 포함될 수 있습니다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Safety alert / Field Safety Notice
  • 사례 ID
    MDA/2013/038
  • 사례 연번
    CON286861
  • 날짜
    2013-06-12
  • 사례 출판 날짜
    2013-06-12
  • 사례 국가
    United Kingdom
  • 사례 출처
    MHRA
  • 사례 출처 URL
    https://webarchive.nationalarchives.gov.uk/20150113054913/http://www.mhra.gov.uk/PrintPreview/MedicalDeviceAlertSP/CON286861?tabName=allTabs
  • 비고 / 경고
    Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, 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 recall data from the U.S. and the United Kingdom.
  • 데이터 추가 비고
  • 원인
    Packaging may be compromised and therefore the sterility of the product cannot be guaranteed. if non-sterile products are used, there is a risk of infection.
  • 조치
    Identify and quarantine affected products. Contact patients who have received affected stock and retrieve any unused devices. Teleflex Medical issued a Field Safety Notice (FSN) on 27 March 2013 recalling all batches of the affected product codes. Return the acknowledgement form to Teleflex and arrange for the return and replacement of unused affected devices. Personnel involved in the purchase, supply and distribution of these devices.

Device

Rusch Belly Bag urine collection bag with hip belt
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Rusch Belly Bag urine collection bag with hip belt. Specific product codes. All lot numbers of the following product codes are affected: Belly Bag, product code B1000 (NHS Supply Chain code GDW502) Belly Bag with 24 inch drain, product code B1000CT Belly Bag with sample port, product code B1000P
  • Manufacturer
    Teleflex Medical

Manufacturer

Teleflex Medical