Events

Brochure titled "Nutrition Compounding Simplified" 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
    29017
  • 사례 위험등급
    Class 3
  • 사례 연번
    Z-0988-04
  • 사례 시작날짜
    2004-04-30
  • 사례 출판 날짜
    2004-07-20
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2006-04-21
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=32980
  • 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
    unknown device name - Product Code LHI--
  • 원인
    The promotional material for the automix/accusource and micromix compounders and micromix compounder implementation guide contain an incomplete accuracy statement regarding the delivery of each ingredient by the compounders.
  • 조치
    Baxter sent Important Product Information letters dated 4/30/04 to all of the compounder customers, informing them of the inaccurate information and requesting that the Nutrition Compounding Simplified brochure, Baxter Info Quick Cards on CD-Rom, versions Q4 2003 and Q2 2003, and pages 60 and 61 of the Micromix Compounder Implementation Guide be destroyed. Replacement pages 60 and 61 of the implementation guide were enclosed with the letter. The letters also listed the accuracy information for each compounder based on Baxter''s supporting data, as well as the specific information regarding the overdelivery alarm limits referenced in the Operator''s Manuals.

Device

Brochure titled "Nutrition Compounding Simplified"
  • 모델명 / 제조번호(시리얼번호)
    Lit #800415, print date January 2002  This brochure was distributed individually and as part of the Baxter Info Quick Card (on CD-Rom), versions Q4 2003 and Q2 2003
  • 유통
    Nationwide, United Kingdom, Germany, Chile, Canada, Brazil, El Salvador, Taiwan, Korea, Italy, Saudi Arabia, Israel, China, Indonesia, Hong Kong, Colombia, Argentina, Mexico, Guatemala, Costa Rica, Panama and Honduras.
  • 제품 설명
    Compounding Brochure titled ''Nutrition Compounding Simplified'', Lit #800415, print date January 2002; the brochure is applicable to the Automix Plus High Speed Compounder System, product 2M8075, the Automix High Speed Compounder System, product 2M8077, the Automix 3+3 Compounder System, product 2M8286, the Automix 3+3 Compounder with Accusource Monitoring System, product 2M8287, the Micromix Compounder System, 1.0 mL, product 2M8290, and the Micromix Compounder System, 0.3 mL, product 2M8290L; Baxter Healthcare Corporation, Clintec Nutrition, One Baxter Parkway, Deerfield, IL 60015
  • Manufacturer
    Baxter Healthcare Corp.

Manufacturer

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