Device Recall Prelude Pro Sheath Introducter 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
    71519
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1826-2015
  • 사례 시작날짜
    2015-06-04
  • 사례 출판 날짜
    2015-06-22
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2015-10-26
  • 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
    Dilator, vessel, for percutaneous catheterization - Product Code DRE
  • 원인
    Some of these introducer sheaths were packaged with a 0.035 inch dilator, rather than the labeled 0.038 inch. this affects one lot, h767887, of catalog number pr0-6f-11-038.
  • 조치
    Merit Medical sent an Urgent Product Recall letter on June 4, 2015, to all affected consignees. Consignees were instructed to immediately quarantine any affected devices and discontinue use, ensure all personnel to whom devices were distributed are made aware of this field action, and instructions to contact their Merit representative. An email notification was sent to Merit sales representatives with accounts that had received affected product. The affected sales representatives were provided a Customer Response Form applicable to their account and a representative copy of communications sent directly to their affected accounts. Merit sales representatives were instructed to visit the account and assist with the return of the affected units back to the Merit Field Assurance Department. Customers with questions were instructed to contact their Merit Sales Representative or call (801) 208-4365.

Device

  • 모델명 / 제조번호(시리얼번호)
    Catalo Number PR0-6F-11-038, Lot Number H767887
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US including TN, NE, MA, SC, WI, UT and Internationally to Belgium, Switzerland, United Kingdom, and Germany.
  • 제품 설명
    Merit Medical Prelude Pro Sheath Introducter, 6F (2.0mm) 11cm, REF PRO-6F-11-038, Sterile EO || The Merit Prelude Sheath Introducer is intended to provide access and facilitate the percutaneous introduction of various devices into veins and/or arteries while maintaining hemostasis for a variety of diagnostic and therapeutic procedures.
  • Manufacturer

Manufacturer

  • 제조사 주소
    Merit Medical Systems, Inc., 1600 West Merit Parkway, South Jordan UT 84095
  • 제조사 모회사 (2017)
  • Source
    USFDA