Events

Resus-EZY Air Cushion Mask 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Schell Medical Corporation 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-01169-1
  • 사례 위험등급
    Class III
  • 사례 시작날짜
    2016-09-07
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01169-1
  • 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
    Schell medical is advising users of an issue regarding product expiry dates for air cushion masks that were purchased between july 2009 and july 2011. these older masks do not have the expiry date shown on the unit label. they do have a lot number, which also doubles as the manufacturing date. this date is shown in the ddmmyy format, e.G lot no. 240511 indicates the mask was manufactured on 24th may 2011. the life of the mask is 5 years, thus in this example this mask has expired and should be discarded.
  • 조치
    Schell Medical is advising users to inspect stock and discard any remaining units of the affected lots. Product manufactured since July 2011 includes the expiry date on the label and is unaffected by this issue. This action has been closed-out on 12/05/2017.

Device

Resus-EZY Air Cushion Mask
  • 모델명 / 제조번호(시리얼번호)
    Resus-EZY Air Cushion MaskCatalogue Number: HP-8400, HP-8401, HP-8402, HP-8403, HP-8404, HP-84505Multiple lot numbers affectedSupplied between July 2009 and July 2011ARTG Number: 143640
  • Manufacturer
    Schell Medical Corporation Pty Ltd

Manufacturer

Schell Medical Corporation Pty Ltd