Device Recall Plum A Infusion Pump 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Hospira 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
    64542
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2678-2017
  • 사례 시작날짜
    2013-02-01
  • 사례 출판 날짜
    2017-07-07
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2018-05-31
  • 사례 출처
    USFDA
  • 사례 출처 URL
  • 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
    A possible interruption of therapy when an e321 error code occurs while using the infuser, which is caused by battery issues.
  • 조치
    Hospira has contracted with Stericycle Inc., in Indianapolis, IN to send letters and a reply form to Hospira customers. Receipt of the letters will be confirmed by UPS tracking. Customers will be requested to return a reply form to Stericycle indicating they have received the letter, and notified their customers. The customers will also be asked to supply the number of Plum A+ infusers at their facility.

Device

  • 모델명 / 제조번호(시리얼번호)
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA (nationwide) including states of: AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, District of Columbia, Puerto Rico and U.S. Virgin Islands; and countries of: Costa Rica and Dominican Republic.
  • 제품 설명
    The Plum A+ Infusion System is a cassette based multifunction infusion system that allows two lines in and one line out and can be used for standard, piggyback, or concurrent delivery. The Plum A+ Infusion System is designed to deliver parenteral, enteral, or epidural infusions over a broad range of infusion rates from multiple fluid container types. The Plum A+ Infusion System includes an infuser, disposable IV sets (hereafter called a set), optional accessories, and this operator's manual. || The Plum A+ Infusion System with Hospira MedNet Software is indicated for use in parenteral, enteral and epidural therapies and the administration of whole blood and blood products.
  • Manufacturer

Manufacturer

  • 제조사 주소
    Hospira Inc., 275 N Field Dr, Lake Forest IL 60045-2579
  • 제조사 모회사 (2017)
  • Source
    USFDA