Events

Device Recall TLC SelfRetaining Retractor Frames 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Applied Medical Technology 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
    73318
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1609-2016
  • 사례 시작날짜
    2016-02-17
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2016-10-27
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=143864
  • 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
    Retractor - Product Code GAD
  • 원인
    The firm received a complaint of an open pouch which breaches the sterilization validation.
  • 조치
    AMT sent an Urgent Medical Device Recall letter dated February 17, 2016 to their customers. The letter identified the affected product, problem and actions to be taken. For questions contact Customer Service at 440-717-4000.

Device

Device Recall TLC SelfRetaining Retractor Frames
  • 모델명 / 제조번호(시리얼번호)
    Part #: TLC200 & TLC300
  • 의료기기 분류등급
    General and Plastic Surgery Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Product was shipped to the following states: AL, AR, AZ, CA, CT, FL, GA, IA, IN, KS, KY, MA, MD, MI, MN, MO, NC, NE, NH, NJ, OH, PA, SC, TN,TX, UT, VA & WI. Product was also shipped to the following countries: Austria, Denmark, Germany, Italy, Japan, Norway, Spain, Sweden, Switzerland & United Kingdom.
  • 제품 설명
    TLC¿ Self-Retaining Retractor Frames SINGLE USE ONLY Rx ONLY (USA) STERILE EO Do Not Resterilize. || Product Usage: || Indicated to aid in tissue retraction during a surgical procedure.
  • Manufacturer
    Applied Medical Technology Inc

Manufacturer

Applied Medical Technology Inc
  • 제조사 주소
    Applied Medical Technology Inc, 8000 Katherine Blvd, Brecksville OH 44141-4202
  • 제조사 모회사 (2017)
    Applied Medical Technology Inc.
  • Source
    USFDA