Device Recall Hospira 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
    32077
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0389-06
  • 사례 시작날짜
    2005-05-18
  • 사례 출판 날짜
    2006-01-12
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2006-12-21
  • 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
    Pump, Infusion - Product Code FRN
  • 원인
    The pump may shut-off prematurely during battery operation without providing adequate response time when 'e320' service warning message appears.
  • 조치
    On 5/18/05, the firm issued letters via Federal Express to all its direct consignees, informing them of the affected products and providing instructions on the recall.

Device

  • 모델명 / 제조번호(시리얼번호)
    List No. 11971-04 Plum A+ I.V. Infusion Pump; List No. 12391-04 Plum A+ I.V. Infusion Pump;  List No. 12618-04 Plum A+3 I.V. Infusion Pump;  List No. 12348-04 Plum A+3 I.V. Infusion Pump.  List Numbers: 12618-04; List Numbers: 11971-36; (shipped 12391-04; (shipped 11971-04; domestically) 11971-04; internationally) 12391-04;  12348-04; 12348-04;  12391-13; 12391-1312391-1   12618-04. All serial numbers of the above list numbered product are included in this correction.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Product was distributed nationwide to 746 domestic consignees. Product was distributed internationally to the following countries: Puerto Rico, Canada, Saudi Arabia, Taiwan, Australia, Italy, Jordan, New Zealand, Spain, Turkey, and United Arab Emirates.
  • 제품 설명
    Hospira brand Plum A+I.V. Infusion Pump, List No. 11971-04; || Hospira brand Plum A+I.V. Infusion Pump, List No. 12391-04; || Hospira brand Plum A+3 I.V. Infusion Pump, List No. 12618-04; || Hospira brand Plum A+3 I.V. Infusion Pump, List No. 12348-04; || Infusion pump is a multi-function fluid delivery infusion system, consisting of pumping module and assortment of IV sets. || Product is manufactured and distributed by || Hospira Inc., 755 Jarvis Dr., Morgan Hill, CA
  • Manufacturer

Manufacturer

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