Events

Device Recall BioFlo PICC (Valved) 5FDL55cm Maximal Barrier Nursing Kit 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Angiodynamics Inc. (Navilyst Medical 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
    80169
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2221-2018
  • 사례 시작날짜
    2018-05-10
  • 사례 상황
    Open, Classified
  • 사례 국가
    United States
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=164760
  • 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
    A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).
  • 조치
    Urgent Medical Device Recall letters were sent to customers on 5/10/18. The letters instructed customers to do the following: IMMEDIATELY Stop using the product subject to recall. Remove any affected (recalled) product from your inventory (whether in labs, Central Supply, Shipping and Receiving or ANY other location). Segregate this product in a secure location for return to AngioDynamics, Inc. Forward a copy of this recall notification to all sites to which you have distributed affected product. Complete and return the Reply Verification Tracking Form. If affected product is located in your institution, please call AngioDynamics Customer Service at 1-800-772-6446 between 8:00 a.m. and 7:00 p.m. (Monday  Friday: Eastern Standard Time) to obtain a replacement or credit for your returned product.

Device

Device Recall BioFlo PICC (Valved) 5FDL55cm Maximal Barrier Nursing Kit
  • 모델명 / 제조번호(시리얼번호)
    UPN: H965750191; Lot: 5301073, 5304893
  • 의료기기 분류등급
    General Hospital and Personal Use Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    The products were distributed to the following US states: AZ, CA, CO, CT, DC, FL, GA, IL, IN, KS, KY, LA, MD, MI, MN, MO, MS, MT, NC, ND, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, WA, WI, and WV. The products were distributed to the following foreign countries: Canada, China, Ireland, Spain.
  • 제품 설명
    BioFlo PICC (Valved) 5FDL-55cm Maximal Barrier Nursing Kit PG, Catalog Number 75-019
  • Manufacturer
    Angiodynamics Inc. (Navilyst Medical Inc.)

Manufacturer

Angiodynamics Inc. (Navilyst Medical Inc.)
  • 제조사 주소
    Angiodynamics Inc. (Navilyst Medical Inc.), 10 Glens Falls Tech Park, Glens Falls NY 12801-3864
  • 제조사 모회사 (2017)
    AngioDynamics Inc
  • Source
    USFDA