Events

Device Recall Fresenius 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Fresenius Hemocare, Inc. 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
    25528
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0906-03
  • 사례 시작날짜
    2003-01-21
  • 사례 출판 날짜
    2003-06-05
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2003-06-04
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=25980
  • 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
    Apparatus, Autotransfusion - Product Code CAC
  • 원인
    Sterility may be compromised.
  • 조치
    On 1/21/03 the firm notified, via telephone, the distributor of the product. The distributor was advised to return any unused product and to contact their customers for return of product. This was followed by a letter 1/21/03 sent via e-mail. The distributor in turn contacted their customers on 1/23/03 by telephone. This was followed by a letter dated 1/23/03.

Device

Device Recall Fresenius
  • 모델명 / 제조번호(시리얼번호)
    ATF 40 Fast Start Kit -  Catalog no. 9108491, batch no. NKT257  AT1: Catalog no. 9005101, lot no. NHT272
  • 의료기기 분류등급
    Anesthesiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    All ATF 40 kits were distributed to one distributor located in MI. The distributor in turn distributed product to 21 hospitals and medical centers in AL, FL, NE, KS, MI, NE, NJ, NY, OH, PA, TX, VA, and WA.
  • 제품 설명
    ATF 40 Fast Start Kit - contains one each AT1 Autotransfusion Set, ATS Suction Line, and the ATR40 Autotransfusion Reservoir. || The component that is the subject of the recall is the AT1 Autotransfusion Set.
  • Manufacturer
    Fresenius Hemocare, Inc.

Manufacturer

Fresenius Hemocare, Inc.
  • 제조사 주소
    Fresenius Hemocare, Inc., 6675 185th Ave. NE, Suite 100, Redmond WA 98052
  • Source
    USFDA