Events

Device Recall SafeStep Huber Needle Set with YInjection Site 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
    76008
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0986-2017
  • 사례 시작날짜
    2016-12-19
  • 사례 출판 날짜
    2017-01-10
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2017-04-17
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=151929
  • 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
    Bard access systems announces a voluntary field action for the safestep¿ huber needle set with y-injection site and miniloc¿ safety infusion set winged without y-injection site devices because sets may contain one or more units where the needle length and gage differs from the length and gage described on the label.
  • 조치
    Bard sent an Urgent Notification letter dated December 16, 2016 to customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to identify and return affected product. For questions call 1-800-290-1689.

Device

Device Recall SafeStep Huber Needle Set with YInjection Site
  • 모델명 / 제조번호(시리얼번호)
    Lot Number: ASZKS076
  • 의료기기 분류등급
    General Hospital and Personal Use Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US Nationwide in the states of CA, CO, FL, GA, HI, IL, MA, MD, NJ, OH, OR, TX.
  • 제품 설명
    SafeStep¿ Huber Needle Set with Y-Injection Site. Product Code: LH-0029YN. Packaged as single units in thermoformed trays. There are 25 SafeStep¿ trays per case and 100 per carton. || Product Usage: || Intended for the administration of fluids and drugs, or blood sampling through surgically implanted vascular ports.
  • Manufacturer
    Bard Access Systems

Manufacturer

Bard Access Systems