National Workplace First Aid Kit & Sports & Outdoors First Aid Kit National Workplace First Aid Kit, Sports & Outdoors First Aid Kit 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 CIP Medical Supplies T/A Caseinpoint 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-2014-RN-00788-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2014-07-15
  • 사례 국가
  • 사례 출처
    DHTGA
  • 사례 출처 URL
  • 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
    It has recently come to case in point's attention that some items in the first aid kits you purchased under the first aid factory brand in the last 12 months contain items labelled as being sterile when they are actually not sterile. this occurred due to a manufacturing error. this issue is unlikely to pose any risk to health, however there is a theoretical risk that the use of an un-sterile wound dressing on an immunocompromised patient could result in an infection. there have been no reports of injuries or adverse events related to this issue.
  • 조치
    Case In Point is recalling the affected kits. Customers returning the affected items for replacement are requested to complete the returns form attached and include the returned items in the prepaid post bag provided with the returns form and send to The First Aid Factory within the next 30 days. Customers returning the affected items for are requested to complete the returns form attached and include the complete first aid kit or refill pack, with the returns form in the prepaid post bag provided and send to The First Aid Factory within the next 30 days. This action has been closed-out on 04/08/2016.

Device

  • 모델명 / 제조번호(시리얼번호)
    National Workplace First Aid Kit & Sports & Outdoors First Aid KitNational Workplace First Aid KitBatch number: 20121214D-WP-L Expiry date: 01/2016Sports & Outdoors First Aid Kit Batch number: 20121214C-S&O; Expiry date: 01/2016ARTG number: 172274
  • Manufacturer