Events

Device Recall Integrated Automated PD Set with Cassette 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
    70062
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1039-2015
  • 사례 시작날짜
    2014-12-08
  • 사례 출판 날짜
    2015-02-02
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2015-10-28
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=132197
  • 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, peritoneal, automatic delivery - Product Code FKX
  • 원인
    Baxter is issuing a recall for one lot of integrated automated peritoneal dialysis set with cassette 3 prong due to complaints received for leakage.
  • 조치
    Baxter sent an Urgent Product Recall notification letter dated January 8, 2015 . The letter identified the affected product, problem and action to be taken. The recalling firm has asked the consignees to 1) locate and remove all affected product from their facilities, 2) contact Baxter to arrange for return and credit, and 3) complete the attached customer reply form and return it to Baxter. For questions call 800-422-9637.

Device

Device Recall Integrated Automated PD Set with Cassette
  • 모델명 / 제조번호(시리얼번호)
    H13L22013
  • 의료기기 분류등급
    Gastroenterology-Urology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    US Nationwide Distribution in the states of FL, WI, AR, TN, TX, NC, MO, NM, NJ, CT, PA, NV, NY, CA, MI, WI, KS, and OH.
  • 제품 설명
    Baxter Integrated APD Set with Cassette 3-Prong, Sterile, nonpyrogenic fluid path. || Product Usage: The recall device is indicated for use in the treatment of patients with renal failure to provide PD fluid exchanges with Baxter HomeChoice PD Systems in clinical and home use settings.
  • Manufacturer
    Baxter Healthcare Corp.

Manufacturer

Baxter Healthcare Corp.
  • 제조사 주소
    Baxter Healthcare Corp., 1 Baxter Pkwy, Deerfield IL 60015-4625
  • 제조사 모회사 (2017)
    Baxter International
  • Source
    USFDA