Events

Device Recall IVEA 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Firefly Medical, 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
    75571
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0767-2017
  • 사례 시작날짜
    2016-11-01
  • 사례 출판 날짜
    2016-12-15
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2017-08-01
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=150828
  • 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
    Stand, infusion - Product Code FOX
  • 원인
    The dowel pin could potentially slip out of its press fit, resulting in the product potentially slumping to one side which could cause the patient to stumble.
  • 조치
    Firm notified customers on **11/18/16** via certified "Urgent: Medical Device Recall (Field Correction) IVEA Model 500A" letter to correct product in the field. Customers were asked to thoroughly read the letter and to immediately follow the actions in the enclosed Product Correction Kit. The instructions include steps for cleaning the correction area and installing the permanent adhesive caps, as well as, completing and returning the product correction form to Firefly Medical. Customers may continue to use their units until the Product Correction actions are complete, as long as pins are not protruding. If the pins are protruding, then customers are to stop using the device immediately and complete the product correction instructions. Customers can call 970-472-5323 or e-mail info@iveamobility.com if they have any questions.

Device

Device Recall IVEA
  • 모델명 / 제조번호(시리얼번호)
    Product Part Number 16100. Serial Numbers 100200-101068, except for serial numbers within this range not released into final inventory for other reasons.
  • 의료기기 분류등급
    General Hospital and Personal Use Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution -- USA and Canada.
  • 제품 설명
    IVEA 500A || Intended for Med-Surg patient care.
  • Manufacturer
    Firefly Medical, Inc.

Manufacturer

Firefly Medical, Inc.
  • 제조사 주소
    Firefly Medical, Inc., 320 E Vine Dr Ste 312, Fort Collins CO 80524-2332
  • 제조사 모회사 (2017)
    Firefly Medical Inc.
  • Source
    USFDA