Boston Sceintific CAPIO™ Polypropylene Blue Monofilament Nonabsorbable Surgical Sutures 의 리콜

New Zealand Medicines and Medical Devices Safety Authority에 따르면, 해당 리콜 는 New Zealand 에서 Teleflex Medical Inc 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
    16399
  • 사례 시작날짜
    2014-03-21
  • 사례 국가
  • 사례 출처
    NZMMDSA
  • 사례 출처 URL
  • 비고 / 경고
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • 데이터 추가 비고
    Recalling Organisation: Boston Scientific NZ Ltd, Level 1, 3 Diamond Street, Newton, Auckland
  • 원인
    Manufacturer has notified that certain lots of their products did not meet minimum needle attachment strength, knot tensile strength, minimum diameter, or minimum resorption strength requirements. this may result in suture breakage, delay in procedure, wound dehiscence, or the need for additional surgical intervention.
  • 조치
    Product to be returned to supplier

Device

  • 모델명 / 제조번호(시리얼번호)
    Model: 833-124, Affected: 02A1200503, 02B1101450 02C0903400, 02D0900010 02D0900103, 02D1003285 02D1003286, 02F1302321 02G1000045, 02G1300348 02G1301122, 02H1100494 02L0803407, 02L1100009 02M1002289, 02M1101933
  • Manufacturer

Manufacturer