Events

Various Tissu-Trans Products 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Precise Medical Supplies 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-2017-RN-01000-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2017-08-29
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01000-1
  • 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
    Results from a visual examination performed on the packaging by the manufacturer shippert medical technologies has revealed that the seal integrity of specific tissu-trans product sterile packages cannot be assured prior to usage without a visual inspection of the seal. to date, shippert has not received any customer complaints or reports of serious injuries and/or deaths due to the lack of sterility.
  • 조치
    1. Remove all affected products and store them in a separate area. These products must not come into clinical use. 2. Forward this letter to all staff members that need to be aware of this information letter and the initiated recall. 3. Contact Precise medical supplies customer service for any additional questions regarding return of the products. 4. Replacement product will be issued and sent for returned products.

Device

Various Tissu-Trans Products
  • 모델명 / 제조번호(시리얼번호)
    Various Tissu-Trans ProductsMega Trans 1500Model Number: SH 3-TT-1500Lot Numbers: 61288, 61464Tissu Trans 100ccModel Number: SH 3-TT-FILTRON 100Lot Numbers: 12018, 12109Tissu Trans 1000Model Number: SH 3-TT-FILTRON 1000Lot Numbers: 12004, 61235Tissu Trans 250Model Number: SH 3-TT-FILTRON 250Lot Numbers: 12019, 61286, 61421Filtron 500Model Number: SH 3-TT-FILTRON 500Lot Numbers: 12002, 12046, 61363ARTG Number: 181259
  • Manufacturer
    Precise Medical Supplies

Manufacturer

Precise Medical Supplies
  • Source
    DHTGA