Events

Device Recall PreludeSYNC Radial Compression Device 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
    76762
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1766-2017
  • 사례 시작날짜
    2017-03-03
  • 사례 출판 날짜
    2017-04-10
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2017-06-21
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=154106
  • 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
    Clamp, vascular - Product Code DXC
  • 원인
    Merit medical systems, inc. announces a voluntary field action for the preludesync radial compression device because particulate generated during the manufacturing process may enter the valve, preventing a complete seal of the inflation valve.
  • 조치
    Merit Medical sent an Urgent Product Recall Notice on March 3, 2017, via letter for consignees to immediately stop using or distributing the affected lots and return them to Merit. For any questions, please contact Merit Customer Service at (801) 208-4381. For further questions regarding this recall, please call (801) 253-1600.

Device

Device Recall PreludeSYNC Radial Compression Device
  • 모델명 / 제조번호(시리얼번호)
    Catalog Number: SRB24AC, Lot Numbers: H1068590S1, H1078177, H1078180, H1083628; Catalog Number: SRB24MED, Lot Numbers: H1068587S1,H1073974, H1078179, H1078181, H1083629, H1083630; Catalog Number: SRB29AC, Lot Numbers: H1068591S1, H1078183, H1083631; Catalog Number: SRB29MED, Lot Numbers: H1068589S1, H1078184, H1078185, H1083633.
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide, Canadian and other foreign consignees. No VA/govt/military consignees.
  • 제품 설명
    The PreludeSYNC Radial Compression Device is a sterile, single use disposable device used to assist in gaining and maintaining hemostasis of the radial and ulnar artery following catheterization procedures. It has a soft wristband with a secure hook and loop fastener. The band delivers adjustable compression of the puncture site with an inflatable bulb, and a check valve for easy inflation and deflation with a syringe. A clear curved backer plate provides optimal visualization of the puncture site and ease of placement.
  • Manufacturer
    Merit Medical Systems, Inc.

Manufacturer

Merit Medical Systems, Inc.
  • 제조사 주소
    Merit Medical Systems, Inc., 1600 W Merit Pkwy, South Jordan UT 84095-2416
  • 제조사 모회사 (2017)
    Merit Medical Systems Inc.
  • Source
    USFDA