Events

TransTissue Filtron 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
    78392
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0170-2018
  • 사례 시작날짜
    2017-10-20
  • 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=159400
  • 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
    System, suction, lipoplasty - Product Code MUU
  • 원인
    Potential breach of sterility of the packaging.
  • 조치
    A n Urgent: Medical Device Recall letter, dated October 20, 2017, was mailed to the user, identifying the affected device and describing the reason for the recall. The letter also provided the risk to health involved and discussed how the user can recognize the failure. Customers were instructed to remove all affected product from their inventory and quarantine them. Additionally, the letter should be forwarded to all necessary staff. Customers are to complete the Recall Response letter within 10 calendar days. Only the affected products listed should be returned per the instructions provided. Questions should be directed to Customer Service at 800-888-8663.

Device

TransTissue Filtron
  • 모델명 / 제조번호(시리얼번호)
    Lot 12004
  • 의료기기 분류등급
    General and Plastic Surgery Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution -- United States, Australia, and Netherlands.
  • 제품 설명
    Tissu-Trans Filtron 1000 Catalog Number 3-TT-FILTRON 1000. || Used for fat transfer and liposuction.
  • Manufacturer
    Shippert Medical Technologies

Manufacturer

Shippert Medical Technologies