Multiple ProcedurePak Trays with Ecolab-Microtek Medical Basin Liners 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-2014-RN-01082-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2014-10-08
  • 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
    Mölnlycke health care has received a recall notification from ecolab-microtek medical regarding basin liners which are contained within procedurepak products. the supplier has identified that very low number of basin liners have small holes or cracks which if present may compromise sterility.
  • 조치
    Molnlycke Healthcare is requesting their customers to isolate any product from the affected batches. Mölnlycke Health Care will arrange for the collection and replacement of the product. This action has been closed-out on 06/06/2016. This action has been closed-out on 06/06/2016.

Device

  • 모델명 / 제조번호(시리얼번호)
    Multiple ProcedurePak Trays with Ecolab-Microtek Medical Basin LinersProcedurePak Trays:Maxillo Facial Pack Rev4, Cairns Base Maxillo Facial Pack Rev4, Cairns Base Limb Rev6SKU: 97006791-05, 97006791-07, 97008210-07Batch ID: 12073320, 12080223, 12168637Basin Liner Product Codes: 2302362-00 & 2309247-00ARTG Numbers: 213220 & 133564
  • Manufacturer

Manufacturer