Events

Baxter EXACTAMIX Inlet, Vented, MicroVolume Inlet 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Baxter Healthcare Corporation 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
    79975
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1910-2018
  • 사례 시작날짜
    2018-04-25
  • 사례 상황
    Open, Classified
  • 사례 국가
    United States
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=164078
  • 비고 / 경고
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • 데이터 추가 비고
    Set, i.V. Fluid transfer - Product Code LHI
  • 원인
    Specific lots of exactamix inlets listed below due to incorrectly performed over-labeling. the inlets were over-labeled with a blank label, or with a label containing an extended expiration date. if the product is used beyond the expiration date,.
  • 조치
    The firm initiated the recall by letter on 04/25/2018. The letter identified the affected product, problem and actions to be taken. the firm requested the return of the product. Distributors were directed to conduct a sub-recall, requesting their customers return the product to the entity from whom they received the product.

Device

Baxter EXACTAMIX Inlet, Vented, MicroVolume Inlet
  • 모델명 / 제조번호(시리얼번호)
    UDI: 00085412475806 Lot Numbers: 802282, 802283
  • 의료기기 분류등급
    General Hospital and Personal Use Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US Distribution
  • 제품 설명
    Baxter EXACTAMIX Inlet, Vented, Micro-Volume Inlet, REF H938175 || Usage: || Exacta-Mix 2400 Compounding System Administration set is a disposable component of a compounding device used in the pharmacy to compound multiple source ingredients into one final solution.
  • Manufacturer
    Baxter Healthcare Corporation

Manufacturer

Baxter Healthcare Corporation
  • 제조사 주소
    Baxter Healthcare Corporation, 1 Baxter Pkwy, Deerfield IL 60015-4625
  • 제조사 모회사 (2017)
    Baxter International
  • Source
    USFDA