Events

Device Recall Baxter Solution Set with DuoVent Spike 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
    59419
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2920-2011
  • 사례 시작날짜
    2011-07-21
  • 사례 출판 날짜
    2011-08-03
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-06-18
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=102723
  • 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
    Intravascular Administration Set - Product Code FPA
  • 원인
    The solution sets are being recalled because the position of the slide clamp and roller clamp may have been reversed during assembly. the reversed orientation of the slide clamp and roller clamp will cause the set to be incorrectly loaded into an infusion pump, resulting in fluid flow from the patient to the pump, rather than from the pump to the patient.
  • 조치
    Baxter Healthcare Corporation sent a "Urgent Product Recall" letter dated July 21, 2011 to all affected customers. The letter included a description of the problem and requested they contact Baxter at 1-888-229-0001 to return all affected product. They were asked to complete and return the attached customer reply form, and to contact and notify their customers. For questions contact Baxter at 1-800-422-9837 during the hours of 8:00 am to 5:00 pm CST.

Device

Device Recall Baxter Solution Set with DuoVent Spike
  • 모델명 / 제조번호(시리얼번호)
    Product Code 1C8507s, lot numbers GR291542, GR292409, GR292797 and GR294454.
  • 의료기기 분류등급
    General Hospital and Personal Use Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    (USA) Nationwide Distribution including the states of Alabama, California, Iowa, Illinois, Indiana, Massachusetts, Maryland, Michigan, North Carolina, New Hampshire, Ohio, Pennsylvania, Tennessee and Virginia.
  • 제품 설명
    Baxter Solution Set with Duo-Vent Spike; 109" (2.8 m), Male Luer Lock Adapter 10 drops/mL. || Baxter Healthcare Corporation. || A sterile, single use, nonpyrogenic fluid pathway for use with rigid nonvented and flexible containers.
  • Manufacturer
    Baxter Healthcare Corp.

Manufacturer

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