VYGON LIFECATH S PICC 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
    58810
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2699-2011
  • 사례 시작날짜
    2011-04-26
  • 사례 출판 날짜
    2011-06-29
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2012-06-01
  • 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, therapeutic, long-term greater than 30 days - Product Code LJS
  • 원인
    Peripherally inserted central catheter has the potential to leak or break at the hub while in use, which could lead to a loss of blood or catheter migration.
  • 조치
    Vygon Corporation sent an "URGENT MEDICAL DEVICE RECALL" letter dated April 26, 2011. The letter identified the affected products, problem, and actions to be taken. The customers were instructed to check inventory and quarantine all affected products; immediately cease use and distribution of all affected products; return any affected products using the instruction from Customer Service involving product pickup (contact Customer Service at 1-800-473-5414 for a Return Merchandise Authorization number); and immediately complete and return the attached form via fax to 215-390-2019. Distributors were provided with instructions on how to handle products that were further distributed. If you have any questions, please contact your local sales representative or Vygon's Customer Service Department at 1-800-473-5414, or by e-,ail at customerservice@yygonus.com.

Device

  • 모델명 / 제조번호(시리얼번호)
    Lot #s: 10101, 10I01, S0792, S0860, S0864, S0882, S1024
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Nationwide Distribution--USA including states of: AZ, CA, FL, MO, NE, NJ, NY, PA, TX, UT, VA, and WA.
  • 제품 설명
    LIFECATH S PICC || Catheter, Percutaneous, Intravascular || Product Code 2296.211 || Product Usage:: Intravascular catheter
  • Manufacturer

Manufacturer