Hospira Plum A I.V. 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
    29982
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0438-05
  • 사례 시작날짜
    2004-09-08
  • 사례 출판 날짜
    2005-01-27
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2005-09-20
  • 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.
    ICU Medical, Inc. acquired from Pfizer in early 2017, Hospira Infusion Systems, the portion of Hospira dedicated to develop infusion pumps.
  • 데이터 추가 비고
    Ph Rate Measurement, Carbon-Dioxide - Product Code JFL
  • 원인
    The batteries in plum a+ and plum a+3 i.V. infusion pumps may fail prematurely when the pump is operating solely on battery power.
  • 조치
    On 9/8/04, all consignees were notified via written letter sent via Federal Express, informing them of the affected products and providing instructions on the recall. The firm will follow up with phone calls to its consignees.

Device

  • 모델명 / 제조번호(시리얼번호)
    The following LIST numbers are under recall. All lots (serial numbers) are currently under recall. LIST No. 11971-04 and LIST No. 12391-04.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    The firm distributed these products to 484 consignees throughout the US, and an undetermined number of foreign consignees. The firm has distributed the product nationwide, excluding AK, HI, NV, NM, SC, and SD. The firm has sent products to Veterans Supply Office Pharmacy, Dept. of Veteran''s Affairs, Vet Admin Medical Center and US Pentitentiary-MC. Foreign countries that have received the product incluide Saudi Arabia, Canada, Puerto Rico and Taiwan.
  • 제품 설명
    The Hospira Plum A+ I.V. Infusion pump is a cassette-based, multi-function fluid delivery infusion system, consisting of pumping module and assortment of IV sets.
  • Manufacturer

Manufacturer

  • 제조사 주소
    Hospira Inc, 755 Jarvis Dr, Morgan Hill CA 95037-2810
  • Source
    USFDA