LifeCare PCA Plus II 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
    52866
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0016-2010
  • 사례 시작날짜
    2009-08-11
  • 사례 출판 날짜
    2009-10-06
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2010-11-30
  • 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
    Infusion Pump - Product Code FRN
  • 원인
    Fire/shock hazard-- a component used in the device may cause sparks/flashes and poses a fire and shock hazard.
  • 조치
    Firm initiated its recall on 08/14/2009. A nationwide press release was issued to AP, and an Urgent: Device Field Correction letter to consignees was sent via UPS. The letter recommended that customers check their infusion pumps and spare parts in their inventory to determine if the specified AC Power Cords are in use at their facility; and, to inspect the affected cords for bent or cracked prongs and bridge connection, burnt plastic, or excessive wear and tear. Also, it was recommended that customers immediately discontinue use of the affected cords exhibiting the described characteristics and contact their local Hospira representative for assistance. The letter stated that customers may continue to use and monitor cords that are not exhibiting the described characteristics until replacement cords are sent to their facility. Hospira will contact customers to schedule replacement. Customers are to complete and return the attached Reply Form. Question should be directed to Hospira Customer Service at 1-800-241-4002.

Device

  • 모델명 / 제조번호(시리얼번호)
    AC power cords Part Numbers: 826-85559-001,  826-85559-003,  826-85559-008,  826-85559-010, and  826-96057-003.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution
  • 제품 설명
    LifeCare PCA Plus II, list #01950-04-03, 01950-04-05, 01950-04-07, 01950-04-51; AC cord manufactured by Electri-Cord, Westfield PA, Infusion pumps manufactured by Hospira, Morgan Hill, CA.
  • Manufacturer

Manufacturer

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