Events

Device Recall Huber Plus NonCoring Needle Safety Infusion Set 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Bard Access Systems 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
    53341
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0861-2010
  • 사례 시작날짜
    2010-01-14
  • 사례 출판 날짜
    2010-02-26
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2010-05-14
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=85298
  • 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, administration, intravascular - Product Code FPA
  • 원인
    After activation of the safety mechanism, the tip of the needle protrudes from the safety sheath creating the potential for needlestick injury.
  • 조치
    Bard Access Systems, Inc. issued and "Urgent: Huber Plus Non-Coring Needle Safety Infusion Set Recall" notification beginning January 2010. Users were instructed to quarantine all affected product and to notify any of their customers that had received the product. Quarantined product is to be returned to the firm. For further information, contact Bard Access Systems, Inc. at 1-800-290-1689.

Device

Device Recall Huber Plus NonCoring Needle Safety Infusion Set
  • 모델명 / 제조번호(시리얼번호)
    Lot Numbers: RETK0229, RETJ0655.
  • 의료기기 분류등급
    General Hospital and Personal Use Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution -- United States (VA, KY, MA, NJ and TN) and Belgium.
  • 제품 설명
    Huber Plus Non-Coring Needle Safety Infusion Set, 19g, 1 inch, Needless Y-site, REF 011901NY, Sterile EO, Assembled In Mexico, Bard Access Systems, Inc., SLC, UT 84116. || Safety IV administration set used to access surgically implanted vascular ports.
  • Manufacturer
    Bard Access Systems

Manufacturer

Bard Access Systems
  • 제조사 주소
    Bard Access Systems, 605 North 5600 West, Salt Lake City UT 84116-3738
  • 제조사 모회사 (2017)
    Becton, Dickinson and Company
  • Source
    USFDA