Events

GEM2755FC (3.5mm) 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
    73908
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1630-2016
  • 사례 시작날짜
    2016-04-21
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2016-11-22
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=145391
  • 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
    Flowmeter, blood, cardiovascular - Product Code DPW
  • 원인
    Instructions for use booklet may puncture the outer tyvek lid.
  • 조치
    Baxter sent an Urgent Product Recall letter dated April 21, 2016 to customer. The letter identified the affected product, problem and actions to be taken. The letters requested that direct consignees contact Synovis MCA to arrange for return and credit. Companies that further distributed the product were asked to notify other facilities or departments. For questions contact Synovis MCA at 800-510-3318 or 205-941-0111.

Device

GEM2755FC (3.5mm)
  • 모델명 / 제조번호(시리얼번호)
    SPI5El2-1049760 thru SPI5K10-1096019
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide and Germany, Sweden, Netherlands, Israel, Denmark, United Kingdom, Canada
  • 제품 설명
    GEM(TM), FLOWCOUPLER(R), 3.5 mm, STERILE EO, Rx only, 1 FLOWCOUPLER, REF GEM2755-FC || Product Usage: || The FlowCOUPLER Device is a single use, implantable device that is intended to be used in the end-to-end anastomosis of veins and arteries normally encountered in microsurgical and vascular reconstructive procedures. The FlowCOUPLER Device includes a pair of permanently implanted rings which secure the anastomosis and a removable Doppler probe that is press-fit onto one of the rings. When the FlowCOUPLER Device is used in conjunction with the FlowCOUPLER Monitor, the FlowCOUPLER System is intended to detect blood flow and confirm vessel patency intra-operatively and post-operatively at the anastomotic site.
  • 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