Events

Jackson-Pratt Perforated and Hemaduct Wound Drainage Systems 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Medline International Two Australia 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-2017-RN-00565-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2017-05-03
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00565-1
  • 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
    Medline is recalling specific jackson-pratt perforated and hemaduct wound drainage systems, due to a potential breach of sterility in the packaging. in a small percentage of product (approximately 1.6%), the inner packaging (polybag) is caught in the seal area of the outer tyvek pouch, potentially compromising the sterility of the package contents. use of impacted products could result in an increased risk of infection. to date, the manufacturer has not received any complaints or reports of infection associated with this issue.
  • 조치
    Medline is advising customers to remove affected codes/lots from their stock holdings and to also segregate affected units for Medline to collect. Medline will organise pick-up of the affected stock and a credit note will be issued.

Device

Jackson-Pratt Perforated and Hemaduct Wound Drainage Systems
  • 모델명 / 제조번호(시리얼번호)
    Jackson-Pratt Perforated and Hemaduct Wound Drainage SystemsProduct Codes: JP-HUR101, SU130-1308, SU130-1309, SU130-1310, SU130-1311 and SU130-1411 Batch Numbers: 1161468, 1161228, 1161396, 1161413, 1161460, 1161461, 1161230, 1161399, 1161247, 1161251, 1161622, 1161623 and 1161253ARTG Number: 169567
  • Manufacturer
    Medline International Two Australia Pty Ltd

Manufacturer

Medline International Two Australia Pty Ltd