Events

Device Recall Baxter System 1000 Delivery System 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Baxter Healthcare Renal Div 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
    30486
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0395-05
  • 사례 시작날짜
    2003-05-28
  • 사례 출판 날짜
    2004-12-02
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2008-02-26
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=35989
  • 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
    System, Dialysate Delivery, Single Patient - Product Code FKP
  • 원인
    The air detector may not detect air bubbles consistently at the selected limit.
  • 조치
    Important Product Information letters were sent to customers on 5/28/03, informing them of the potential for the air detector not detecting air bubbles consistently. The letters instructed the accounts to measure the air detector sensor voltage output on each of their instruments, using the enclosed instructions, to determine whether the installation of an air detector attenuator connector is needed. The instructions also included directions for installation of the attenuator connector. Since the instrument requires re-qualification after the testing and installation, the accounts were given the choice to have the testing and installation done during the next service call or as part of the instrument''s next normally scheduled maintenance.

Device

Device Recall Baxter System 1000 Delivery System
  • 모델명 / 제조번호(시리얼번호)
    All System 1000 units with serial numbers prior to 22224.
  • 의료기기 분류등급
    Gastroenterology-Urology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    The devices were distributed nationwide and internationally to Baxter subsidiaries in Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Denmark, Ecuador, Finland, France, the Republic of Georgia, Greece, Guatemala, Honduras, Hong Kong, India, Indonesia, Ireland, Israel, Italy, Korea, Lebanon, Malaysia, Morocco, the Netherlands, Oman, Palestine, Panama, Peru, the Philippines, Poland, Romania, Russia, Saudi Arabia, Singapore, Slovakia, Spain, Sweden, Taiwan, Thailand, Tunisia, Turkey and the United Kingdom.
  • 제품 설명
    Baxter System 1000 Single Patient Hemodialysis Delivery System; Model SYS1000; all series 1000 instruments labeled as System 1000, AltraTouch 1000, Baxter Tina and Baxter Aurora; Baxter Healthcare Corporation, Deerfield, IL 60015 USA or Baxter Healthcare Corporation, McGaw Park, IL 60085 USA
  • Manufacturer
    Baxter Healthcare Renal Div

Manufacturer

Baxter Healthcare Renal Div
  • 제조사 주소
    Baxter Healthcare Renal Div, 1620 Waukegan Rd Bldg R, Mc Gaw Park IL 60085-6730
  • Source
    USFDA