Events

Device Recall Alaris Medley LVP Bezel Assembly 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Elite Biomedical Solutions 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
    71543
  • 사례 위험등급
    Class 1
  • 사례 연번
    Z-2372-2015
  • 사례 시작날짜
    2015-06-03
  • 사례 출판 날짜
    2015-08-20
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2017-03-07
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=138352
  • 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
    Administration of inappropriate quantities of fluid can result, with the potential to cause injury or death.
  • 조치
    Elite Biomedical Solutions, sent a "Product Advisory Notices" letter dated May 21, 2015 to their customers. On June 3, 2015 the firm sent an Urgent Medical Device Recall letter to their customers. The letter identified the affected product , problem and actions to be taken. And on June 12, 2015 a press release was issued via ECRI (Emergency Care Research Institute) to all hospitals in the US. The notification letter requested customers to: 1) inspect and quarantine affected products, 2) identify your customers and notify them at once of this product recall, and 3) complete and return the enclosed response forms. For any questions, call Elite Biomedical Solutions, LLC, Quality Manager, at 1-855-291-6701.

Device

Device Recall Alaris Medley LVP Bezel Assembly
  • 모델명 / 제조번호(시리얼번호)
    P/N 49000204 Lot #'s 031815100, 032415100, 04061545 and 043015215
  • 의료기기 분류등급
    General Hospital and Personal Use Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution in the states of AZ, CA, GA, IL, IN, KS, KY, MA, MD, MN, MO, MS, NC, NY, OH, PA, SC, TN, TX, VA & WI.
  • 제품 설명
    Alaris Medley LVP Bezel Assembly. || Intended use to hold platen assembly and help protect the bezel assembly's internal components from fluid intrusion. This part is used in the Alaris Medley LVP 8100 infusion pump.
  • Manufacturer
    Elite Biomedical Solutions LLC

Manufacturer

Elite Biomedical Solutions LLC
  • 제조사 주소
    Elite Biomedical Solutions LLC, 5150 Fordon Ct, Cincinnati OH 45244-5021
  • 제조사 모회사 (2017)
    Elite Biomedical Solutions Llc
  • Source
    USFDA