Events

Device Recall Curlin Infusion Administration Set 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 MOOG Medical Devices Group 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
    61446
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1401-2012
  • 사례 시작날짜
    2012-03-20
  • 사례 출판 날짜
    2012-04-13
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-07-26
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=108166
  • 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
    Pump, infusion - Product Code FRN
  • 원인
    Ambulatory administration sets used with the curlin ambulatory pumps including the 4000 cms ambulatory pump, 6000 cms ambulatory pump and the pain smart iod ambulatory pump may leak during use.
  • 조치
    Moog Medical Device Group sent a Medical Device Recall Notification letter dated March 20, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to remove the affected product from their inventory, contact the distributor or Moog Customer Service at 1-800-970-2337, prompt #7, then return product to distributor or Moog. For additional questions regarding this recall call Moog's Customer Service Department at (800) 970-2337.

Device

Device Recall Curlin Infusion Administration Set
  • 모델명 / 제조번호(시리얼번호)
    Product Number: 340-4114 Lot Numbers: CF1120905,,, CF1120906,,, CF1120907,,, CF1122240,,, CF1122242,,, CF1122241,,, CF1124301,,, CF1124302,,, CF1125501,,, CF1125118,,, CF1125515,,, CF1125117,,, CF1125116,,, CF1127114,,, CF1127115,,, CF1127116,,, CF1127918,,, CF1127917,,, CF1129208,,, CF1129209,,, CF1129210,,, CF1129901,,, CF1129902,,, CF1129903,,, CF1129906,,, CF1130601,,, CF1131103,,, CF1131104,,, CF1132015
  • 의료기기 분류등급
    General Hospital and Personal Use Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA including AZ,,, CA,,, FL,,, GA,,, KS,,, IL,,, MA,,, MD,,, MI,,, OH,,, PA,,, TX,,, VA,,, WI,,, and the countries of Germany,,, Italy,,, Morocco,,, New Zealand,,, and the United Arab Emirates,,,
  • 제품 설명
    Non-DEHP Microbore Administration Set with Non-Vented Spike Packaged Assembly || The Curlin Ambulatory Infusion Pump System with disposable PVC Administration Tubing Sets and user accessories, provide a means for the volumetric delivery of fluids used in Parenteral, Enteral, Epidural, Subcutaneous and Intravenous applications.
  • Manufacturer
    MOOG Medical Devices Group

Manufacturer

MOOG Medical Devices Group
  • 제조사 주소
    MOOG Medical Devices Group, 4314 Zevex Park Ln, Salt Lake City UT 84123-7881
  • 제조사 모회사 (2017)
    Moog Inc
  • Source
    USFDA