Neonatal Catheter & Insertion Tray is simply a catheter kit that is comprised of the Nutriline Peelable Sheath 2 Fr. catheter and a separately packaged catheter tray. 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Vygon 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
    26213
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0850-03
  • 사례 시작날짜
    2003-04-09
  • 사례 출판 날짜
    2003-05-20
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2006-10-03
  • 사례 출처
    USFDA
  • 사례 출처 URL
  • 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
    Catheter, Intravascular, Diagnostic - Product Code DQO
  • 원인
    Nutriline with peelable sheath 2 fr. and neonatal catheter & insertion tray were packaged with a 3 fr. insertion sheath.
  • 조치
    Recalls letters were sent out to customers and sales representatives on 4/9/2003. They were also notified via e-mails and phone calls on 4/9/2003.

Device

  • 모델명 / 제조번호(시리얼번호)
    Lot #031203MA Exp. 7/1/2005
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Product was only distributed domestically to customers and sales representatives in MA, NY, GA, FL, OH, CO, and CA. There are no Govt. accounts.
  • 제품 설명
    Neonatal Catheter & Insertion Tray is simply a catheter kit that is comprised of the Nutriline Peelable Sheath 2 Fr. catheter and a separately packaged catheter tray. The catheter tray and its respective accessories are manufactured in the US by Vygon. Sterilization of this catheter tray occurs via EtO by North American Sterilization and Packaging, Franklin, NJ. Labeled as Neonatal Catheter & Insertion Tray.
  • Manufacturer

Manufacturer

  • 제조사 주소
    Vygon Corporation, 1 Madison Street, East Rutherford NJ 07073
  • Source
    USFDA