Events

AutoSuture 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Ascent Healthcare Solutions, 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
    37162
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0414-2007
  • 사례 시작날짜
    2006-10-19
  • 사례 출판 날짜
    2007-02-08
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2008-10-31
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=50019
  • 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
    Endoscopic Trocar - Product Code NLM
  • 원인
    The tip of the trocars may separate before and while in use. in some instances the trocars have been found with exposed blades upon opening the packaging.
  • 조치
    The recall was initiated on 10/19/2006 by direct distribution of the recall notice to direct accounts by the firm's sales force. The firm also posted the notification on their web site. All customers were instructed to examine their inventories for the product and to remove and quarantine all affected product. Instructions on returning the product to the firm were also included along with a response form.

Device

AutoSuture
  • 모델명 / 제조번호(시리얼번호)
    94724 95261 104057 94853 95272 104217 94893 100062 104335 94894 102389 104337 94897 102394 104343 94953 102681 104584 94957 102851 105517 94962 103100  94964 103103  95024 103200  95026 103288  95029 103293  95069 103297  95135 103566  95259 103570
  • 의료기기 분류등급
    Gastroenterology-Urology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide
  • 제품 설명
    AutoSuture Bladed Trocar, equipped with safety shield. Model number 179094. Available with smooth or threaded sleeve in sizes 5-15mm inner diameter and 70-100mm length.
  • Manufacturer
    Ascent Healthcare Solutions, Inc.

Manufacturer

Ascent Healthcare Solutions, Inc.
  • 제조사 주소
    Ascent Healthcare Solutions, Inc., 5307 Great Oak Dr, Lakeland FL 33815
  • Source
    USFDA