Events

Actifuse ABX and Actifuse MIS System 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Baxter Healthcare 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-2015-RN-00774-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2015-08-25
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00774-1
  • 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
    Baxter healthcare is issuing a recall of actifuse abx and actifuse mis system products with expiry before 29 july 2017 due to the possibility that the products may have endotoxin levels above specification criteria. in surgical procedures where there is device contact with the cerebrospinal fluid through a dural opening (iatrogenic injury), the use of a medical device with increased endotoxin levels may augment the typical inflammatory reaction to surgery and contribute to adverse health consequences. baxter has not received product-related adverse event reports that can be linked to cerebrospinal fluid exposure to increased levels of endotoxins.
  • 조치
    Users are asked to inspect their stock and to remove affected product from their facility and to contact Baxter Customer service to arrange replacements. This action has been closed-out on 05/09/2016.

Device

Actifuse ABX and Actifuse MIS System
  • 모델명 / 제조번호(시리얼번호)
    Actifuse ABX and Actifuse MIS SystemProduct Codes: 506005078047 Actifuse ABX, 1-2 mm, 2.5 mL506005078048 Actifuse ABX, 1-2 mm, 5.0 mL506005078049 Actifuse ABX, 1-2 mm, 10.0 mL506005078057 Actifuse ABX, 1-2 mm, 20.0 mL,506005078059 Actifuse ABX, 1-2 mm, 1.5 mL506005078069 Actifuse MIS System, 1-2 mm, 7.5 mL506005078071 Actifuse MIS System Refill, 1-2 mm, 7.5 mLLot Numbers: ALLARTG Numbers: 188736 & 193684
  • 의료기기 분류등급
    Orthopedic Devices
  • Manufacturer
    Baxter Healthcare Pty Ltd

Manufacturer

Baxter Healthcare Pty Ltd