Events

SURGICAL GOWN UL HP L (Molnlycke Health Care Pty Ltd - Gown, operating room, single use) 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-2017-RN-01433-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2017-11-23
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01433-1
  • 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
    During internal rigorous quality checking, mölnlycke has self-identified a quality issue with specific batches of gowns released between october 6th till october 16th 2017. the issue is regarding foreign particles (loose threads) being identified on the products.No complaints or reports of patient harm related to this issue have been received as of november 2017.
  • 조치
    Customers are requested to; 1. Identify and isolate all affected, BARRIER Ultimate Surgical Gown at your facility; 2. Complete the confirmation form supplied with the customer letter and e-mail/fax back per its instructions. Even if you no longer have any concerned BARRIER Ultimate Surgical Gown, Mölnlycke needs to be sure all customers are aware of the situation; 3. Mölnlycke will contact you and arrange for collection of the product(s) from your facility, as soon as you return the confirmation form. Mölnlycke will organize to issue a credit for the goods returned; and 4. If you have forwarded any affected products to other healthcare institutions, send them a copy of the customer letter together and make sure they act accordingly.

Device

SURGICAL GOWN UL HP L (Molnlycke Health Care Pty Ltd - Gown, operating room, single use)
  • 모델명 / 제조번호(시리얼번호)
    SURGICAL GOWN UL HP L (Molnlycke Health Care Pty Ltd - Gown, operating room, single use)Product number: 6901021-01Batch number: 17357759ARTG number: 138941
  • Manufacturer
    Molnlycke Health Care Pty Ltd

Manufacturer

Molnlycke Health Care Pty Ltd