Events

Device Recall TransTissue Product Line 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Shippert Medical Technologies 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
    77518
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-3066-2017
  • 사례 시작날짜
    2017-06-01
  • 사례 상황
    Open, Classified
  • 사례 국가
    United States
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=156214
  • 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
    unknown device name - Product Code N/A
  • 원인
    Seal integrity of the tissu-trans product sterile packages cannot be assured.
  • 조치
    Customers were notified of the recall between 06/01/2017 and 06/14/2017 via FedEx letter. Instructions included remove and quarantine all affected devices, complete and return the response form, arrange for the return of affected devices, and notify any customers if further distributed.

Device

Device Recall TransTissue Product Line
  • 모델명 / 제조번호(시리얼번호)
    Lot Numbers 12079, 61117, 61143, 61405.
  • 유통
    Worldwide Distribution - US Nationwide in the states of: AL, AR, AZ, CA, CO, CT, FL, GA, HI, IL, IN, KS, KY, MD, MI, MN, MO, NC, NJ, NV, NY, OH, OR, PA, TN, TX, UT, VA, WA, WV. and the countries of: Italy, Austria, Turkey, United Arab Emirates, Germany, Spain, Saudi Arabia, Switzerland, Japan Kuwait, Denmark, Sweden, United Kingdom, Belgium, France, Australia, Netherlands, Greece, South Korea.
  • 제품 설명
    Tissu-Trans SFILL 360, 3-TT-SFILL 360. || Product Usage: || Intended for fat transfer and liposuction.
  • Manufacturer
    Shippert Medical Technologies

Manufacturer

Shippert Medical Technologies