Events

Lipofilter 3000 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 MicroAire Surgical Instruments, LLC 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
    61853
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1792-2012
  • 사례 시작날짜
    2012-04-26
  • 사례 출판 날짜
    2012-06-09
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-11-21
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=109241
  • 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
    Apparatus, suction, single patient use, portable, nonpowered - Product Code GCY
  • 원인
    Medical device was not manufactured under good manufacturing procedures and a user may be unable to sterilize the device according to procedures.
  • 조치
    MicroAire Surgical Instrument sent a Device Removal Notice letter dated April 26, 2012 to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers were advised to recover the affected product from inventory and quarantine. Customers were instructed to contact MicroAire Customer Service Department at 800-975-8000 or 434-975-8000 to arrange for return and replacement of the affected product. For questions call 434-975-8336 or email toddm@microaire.com.

Device

Lipofilter 3000
  • 모델명 / 제조번호(시리얼번호)
    Lot Number: 0312200152
  • 의료기기 분류등급
    General and Plastic Surgery Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    US Nationwide Distribution including the states of CA, OH and NY.
  • 제품 설명
    Lipofilter 3000, model ASP-CAN-2, labeled in part ***MicroAire, 1641 Edlich Drive, Charlottesville, VA 22911, USA*** || Product Usage: || A fat collection canister intended for use during liposuction procedures.
  • Manufacturer
    MicroAire Surgical Instruments, LLC

Manufacturer

MicroAire Surgical Instruments, LLC
  • 제조사 주소
    MicroAire Surgical Instruments, LLC, 1641 Edlich Dr, Charlottesville VA 22911-5839
  • 제조사 모회사 (2017)
    Colson Associates Inc.
  • Source
    USFDA