Events

9025RHTR ABG Sampling Kit 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 CareFusion Australia 316 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-01226-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2017-09-26
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01226-1
  • 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
    Carefusion have been advised of an issue with a specific lot of 9025rhtr abg sampling kits. these kits should contain a sub-assembly comprised of a 25 gauge needle, with 1ml syringe, and 3.12 international units (iu) of heparin. an error in manufacturing of one lot of the 9025rhtr abg kit(s) has been identified as incorrectly containing a sub-assembly which includes a larger needle (23 gauge needle), larger syringe (3ml), and larger amount of heparin (113iu), than what is intended for the kit.To date, no reports relating to this issue have been receivedin australia, and carefusion is not aware of any report of injury attributed to this defect in australia.
  • 조치
    1. Discontinue use of and segregate the above identified Lot Numbers of Catalogue Number 9025RHTR ABG Sampling Kit with lot number 0001047501. 2. CareFusion is requesting any impacted inventory be set aside for collection. 3. Users are to Complete the supplied Customer Acknowledgement Form to confirm receipt of this notification and return to CareFusion as directed. 4. CareFusion will then arrange for the pick-up of your affected stock and issue a credit.

Device

9025RHTR ABG Sampling Kit

Manufacturer

CareFusion Australia 316 Pty Ltd