Events

Device Recall Baxter 6060 MultiTherapy Infusion Pump 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Baxter Healthcare Corp. 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
    28037
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0376-04
  • 사례 시작날짜
    2003-12-17
  • 사례 출판 날짜
    2004-01-29
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2006-11-28
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=31080
  • 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 and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel data.
  • 데이터 추가 비고
    unknown device name - Product Code FRN--
  • 원인
    Premature motor failure.
  • 조치
    Baxter sent letters dated 12/17/03 to all Baxter 6060 Multi-Therapy Infusion Pump accounts that received pumps manufactured with the affected motors or who had their pumps refurbished with affected motors. The letters included a list of affected pump serial numbers for each facility. The accounts were informed of the possible premature motor failure, and were requested to contact Baxter via fax to schedule a service call to correct the pumps.

Device

Device Recall Baxter 6060 MultiTherapy Infusion Pump
  • 모델명 / 제조번호(시리얼번호)
    serial numbers 108050HR, 108183HR, 108298HR, 109036HR, 109216HR, 109622HR, 110004HR, 110700HR, 111126HR, 111270HR, 111540HR, 112441HR, 201178HR, 308361HR/308440HR, 309001HJ/309030HJ, 309001HR/309345HR 309001HW/309015HW, 310001HG/310010HG , 310001HW/310010HW , 310007HR/310088HR, and HR1976/HR27480. Only those pumps within these serial numbers with installed motor assemblies from date codes 33/03, 34/03 and 35/03 are affected.
  • 의료기기 분류등급
    General Hospital and Personal Use Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    The product was distributed nationwide, and internationally to Sweden, Germany, the United Kingdom, Australia and Japan.
  • 제품 설명
    Baxter 6060 Multi-Therapy Infusion Pump, product code 2M9832; Manufactured by an affiliate of Baxter Healthcare Corp., Deerfield, IL 60013 USA, made in Singapore
  • Manufacturer
    Baxter Healthcare Corp.

Manufacturer

Baxter Healthcare Corp.
  • 제조사 주소
    Baxter Healthcare Corp., Rt 120 & Wilson Rd, Round Lake IL 60073
  • Source
    USFDA