Protg "GPS" SelfExpanding Biliary Stent System 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Ev3, 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
    57112
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0626-2011
  • 사례 시작날짜
    2010-10-30
  • 사례 출판 날짜
    2010-12-16
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2012-03-29
  • 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, biliary, diagnostic - Product Code FGE
  • 원인
    Mislabeled size: specific prot¿g¿ gps lots have product labeling that does not match the actual stent sizes contained in the packages. the affected product outer packaging is labeled as a 12 mm x 60 mm prot¿g¿ gps stent but contains a 14 mm x 60 mm stent. this situation can potentially result in vessel damage. conversely, a lot was labeled as a 14 mm x 60 mm prot¿g¿ gps stent but actually contai.
  • 조치
    ev3 issued a "Medical Device Recall" letter dated September 29, 2010 to consignees. The letter described the product, Issue Summary, & Required Action. Consignees are to review inventory and remove all affected devices. ev3 representatives will contact customers to arrange for the return and credit of unused product. ev3 can be reached at 800 716-6700 concerning this recall.

Device

  • 모델명 / 제조번호(시리얼번호)
    Lot 9199844 (REF SERB65-12-60-80) & 9199842 (REF SERB65-14-60-80).
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Nationwide Distribution: including the states of AZ, DE, C, FL, GA, ID, IL, IN,LA, MN, MO, NJ, NY, NC, OH, VA, and WA.
  • 제품 설명
    ev3 Inc. 4600 Nathan Lane, Plymouth, MN Prot¿g¿ " GPS" Self-Expanding Biliary Stent System, Sterile EO, 14 mm 60mm 80 cm, REF SERB65-14-60-80, Rx only. || ev3 Inc. 4600 Nathan Lane, Plymouth, MN Prot¿g¿ " GPS" Self-Expanding Biliary Stent System, Sterile EO, 12 mm 60mm 80 cm, REF SERB65-12-60-80, Rx only.
  • Manufacturer

Manufacturer

  • 제조사 주소
    Ev3, Inc., 4600 Nathan Ln N, Plymouth MN 55442-2890
  • 제조사 모회사 (2017)
  • 제조사 의견
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    USFDA