Events

Leongatha Delivery Pack containing umbilical clamps 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Molnlycke Health Care Pty Ltd 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

의료기기에 문제가 생겼을 경우 제조사가 이를 바로잡거나 시장에서 회수하는 조치를 말한다. 회수(Recall)는 의료기기에 결함이 있거나, 건강에 위협이 되거나, 또는 결함도 있고 건강에도 위협이 될 경우에 발생한다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall
  • 사례 ID
    RC-2016-RN-01043-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2016-08-09
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01043-1
  • 비고 / 경고
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • 데이터 추가 비고
  • 원인
    Mölnlycke health care has become aware of situations where the umbilical clamp included in the procedurepak kits and trays may have been incorrectly used due to a lack of adequate instructions for use. if the clamp is used incorrectly i.E. both hooks in the clamp are not engaged, the clamp may reopen. if the clamp is not in place correctly when the umbilical cord has been cut, this can potentially lead to blood loss for the baby if not monitored regularly.The ifu will be improved to include further instruction to ensure correct usage of the clamps.
  • 조치
    Mölnlycke Health Care is providing users with the correct instructions for the umbilical clamp. To ensure correct usage: - Rotate the umbilical cord clamp with the open side of the lock towards you, so that you can see the locking hooks. - Place the (thick) umbilical cord towards the ring end. - Both hooks must be correctly positioned, check carefully that both hooks are securely clicked into place. Incorrect engagement of the hooks can cause the clamp to open. This action has been closed-out on 17/02/2017.

Device

Leongatha Delivery Pack containing umbilical clamps
  • 모델명 / 제조번호(시리얼번호)
    Leongatha Delivery Pack containing umbilical clampsProduct number: 97047649-01Umbilical clamps ref.: IFKR21 and 2305123-00All batches are affectedARTG Number: 133562
  • Manufacturer
    Molnlycke Health Care Pty Ltd

Manufacturer

Molnlycke Health Care Pty Ltd