Events

Device Recall Convenience Kit. Inflation Custom Kit 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Merit Medical Systems, 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
    27525
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0140-04
  • 사례 시작날짜
    2003-10-01
  • 사례 출판 날짜
    2003-11-19
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2004-02-02
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=30010
  • 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
    There is a potential for the petg blister trays to bond together with varying degrees of attachment. the potential for non-sterility exists when the attached trays are seperated by force and holes or cracks are generated in the seperated trays.
  • 조치
    Merit notified sales representatives, domestic and international accounts and dealers immediately by letter dated October 3, 2003. The manufacturer requests that the use of the affected inventory should immediately cease and that on-hand units should be promptly isolated from general inventory for simultaneous inspection by a site representative and a Merit sales representative.

Device

Device Recall Convenience Kit. Inflation Custom Kit
  • 모델명 / 제조번호(시리얼번호)
    Lot # A286536 # A286573  #A284710, #A286572, #A284696, #A286544, #A289876, #A286529, #A286569, #A286538 #A290146, #A287547, #A284668, #A286552 #A284703, #A287540, #A286565, #A284616  #A284618, #A286535, #A286547, #A284998  #A284694, #A284617, #A286560, #A286542  #A286550, #A287554, #A287553, #A279791 #A290033, #A290053, #A286541, and #A283067.
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Distributed nationwide. International distribution includes Canada, Japan, Korea, England and France.
  • 제품 설명
    Inflation Kit. Label reads in part: ''CUSTOM KIT...MERIT MEDICAL''. Latex free, Sterile if package is unopened or undamaged. Part Numbers: K05-00122H, K05-50031D, K0510570, K05-01536A, K05-01153C, K05-00276C, K05-0019313, K05-00077F, K05-01296A, K05-00134D, K05-01676, K05-01250, K05-00800, K05-01545, K05-00819, K05-01069C, K05-00559F, K05-50078B, K05-00116C, K05-00459C, K05-01290A,K05-01146, K05-50054D, K05-00946B, K05-00203K, K05-00682B, || K05-YSI008A, K05-YPI011, K05-00746, K05-003139, K05-00751G,K05-00180G, and K05-00553F.
  • Manufacturer
    Merit Medical Systems, Inc

Manufacturer

Merit Medical Systems, Inc
  • 제조사 주소
    Merit Medical Systems, Inc, 1600 Merit Pkwy, South Jordan UT 84095-2416
  • Source
    USFDA