Events

Device Recall Baxter NonDEHP MicroVolume Extension Set 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
    63898
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2687-2016
  • 사례 시작날짜
    2012-12-14
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2016-12-23
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=114970
  • 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
    Set, administration, intravascular - Product Code FPA
  • 원인
    Some of the individual extension set packages were improperly sealed, compromising the sterility of the product.
  • 조치
    Baxter sent an Urgent Product Recall notification letter dated December 14, 2012, to all affected customers. Baxter instructed customers to locate and remove all affected product from their facility. Customers were instructed to contact Baxter Healthcare Center for Service to arrange for return of product and credit and to complete the attached Customer Reply Form and return it to Baxter or scanned email. Customers with questions should call 1-888-229-0001. For questions regarding this recall call 800-422-9837.

Device

Device Recall Baxter NonDEHP MicroVolume Extension Set
  • 모델명 / 제조번호(시리얼번호)
    product code 2N3345, lot number UR12E03108
  • 의료기기 분류등급
    General Hospital and Personal Use Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US including FL, GA, IL, KS, KY, MI, MO, NC, ND, OH, PA, SC, TN, TX, WV, Puerto Rico and Internationally to Canada.
  • 제품 설명
    Baxter Non-DEHP Micro-Volume Extension Set, Male Luer Lock Adapter, 36 (91 cm), Volume 0.32 mL; an Rx sterile, single use nonpyrogenic fluid pathway; 50 sets per case; || For the administration of drugs and solutions to a patient's vascular system through a vascular access device.
  • Manufacturer
    Baxter Healthcare Corp.

Manufacturer

Baxter Healthcare Corp.
  • 제조사 주소
    Baxter Healthcare Corp., Route 120 And Wilson Rd, Round Lake IL 60073-9799
  • 제조사 모회사 (2017)
    Baxter International
  • Source
    USFDA