Events

Liquid Bicarbinate 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Rockwell Medical Technologies, 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
    49580
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0440-2009
  • 사례 출판 날짜
    2009-01-05
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2010-07-29
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=73837
  • 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
    dialysate concentrate for hemodialysis (liquid) - Product Code KPO
  • 원인
    Microbial growth was observed in the retain samples of 4 lots of liquid bicarbonate after products had been distributed.
  • 조치
    Recall notification was faxed and/or e-mailed to consignees on 09/29/08 and then sent via mail on 09/30/08. A follow-up response form was faxed to consignees starting 10/01/08. Consignees asked to return product for a credit. For additional information, contact Rockwell Medical Technologies, Inc., Customer Service at 1-800-449-3353.

Device

Liquid Bicarbinate
  • 모델명 / 제조번호(시리얼번호)
    Lot #10445.
  • 의료기기 분류등급
    Gastroenterology-Urology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide. Product distributed to AL, AR, FL, GA, NC, SC, TN, TX, and VA.
  • 제품 설명
    SteriLyte¿¿ Liquid Bicarbinate, Formula RL-01; 1 gallon (3.78 L); manufactured by Rockwell Medical Technologies, Inc., Grapevine, TX 76051. This product is used in conjunction with C-Series RenalPure¿¿ Liquid Acid Concentrate or DC-Series Dri-Sate¿¿ Dry Acid Concentrate in artificial kidney (hemodialysis) machines.
  • Manufacturer
    Rockwell Medical Technologies, Inc

Manufacturer

Rockwell Medical Technologies, Inc
  • 제조사 주소
    Rockwell Medical Technologies, Inc, 4051 Freeport Pkwy Ste 100, Grapevine TX 76099
  • 제조사 모회사 (2017)
    Rockwell Medical Inc.
  • Source
    USFDA