Events

Fluid Administration Sets 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Merit Medical Systems, 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
    75011
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0649-2017
  • 사례 시작날짜
    2016-08-12
  • 사례 출판 날짜
    2016-11-21
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2017-05-09
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=149111
  • 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
    Merit medical systems, inc. announces a voluntary field action for fluid administration sets due to a molding defect in the drip chamber.
  • 조치
    Consignees were notified via an Urgent Product Recall Notice on 8/12/16 to: 1. Please immediately determine if any of the devices are within your facility, quarantine them, and discontinue use. 2. Ensure that all personnel to whom the devices were distributed are made aware of this field action. 3. Complete the Customer Response Form and return it to Merit Medical Systems with any affected products. If you have no affected products, please complete the Customer Response Form. 4. E-mail the completed Customer Response Form to Customer Service at RESPONSE@merit.com, or fax to (801) 316-4880. 5. If you have any questions concerning this communication or for assistance arranging product return, please dont hesitate to contact your Merit Sales Representative or Vicki Biehn at vbiehn@merit.com or at (801) 208-4260.

Device

Fluid Administration Sets
  • 모델명 / 제조번호(시리얼번호)
    Part Number: 701610001, K08-02053A, K08-02111A, K-08-2192A, K08-02385, K08-02385P, K08-02649, K08-02690, K08-02930a, K08-03044, K08T-02829, K09-00807AD, K09-01467AC, K09-01467AD, K09-01732N, K09-02334N, K09-02608A, K09-03491HP, K09-03586AC, K09-03743L, K09-04300Q, K09-04775HP, K09-04916JP, K09-05525A, K09-05648GP, K09-05993F, K09-07692D, K09-08374C, K09-08485F, K09-08556G, K09-08592N, K09-08603B, K09-08720G, K09-08720H, K09-08743L, K09-08743M, K09-08790C, K09-08813J, K09-09067C, K09-09144B, K09-09221CP, K09-09280A, K09-09326, K09-09418CP, K09-09439, K09-09474H, K09-09527D, K09-09657AP, K09-09672AP, K09-09677A, K09-09683l, K09-09683LP, K09-09859FP, K09-09966AP, K09-09966BP, K09-09983A, K09-10008C, K09-10009D, K09-10312, K09-10457C, K09-10590, K09-10593A, K09-10745BP, K09-10784A, K09-10800CP, K09-10870C, K09-10915F, K09-10947J, K09-10947LP, K09-10992CP, K09-11004F, K09-11004FP, K09-11132CP, K09-11132DP, K09-11137A, K09-11165B, K09-11259B, K09-11270A, K09-11303, K09-11303A, K09-11306, K09-11309D, K09-11336B, K09-11389, K09-11433F, K09-11452AP, K09-11530P, K09-11549D, K09-11655A, K09-11704, K09-11796C, K09-11796CP, K09-11867AP, K09-11901B, K09-11912, K09-11923C, K09-11940AP, K09-11971B, K09-12000, K09-12000A, K09-12006, K09-12065CP, K09-12065D, K09-12065DP, K09-12123A, K09-12138, K09-12138A, K09-12138B, K09-12216, K09-12276, K09-12304, K09-12305, K09-12356, K09-12376, K09-12393, K09-12408, K09-12408A, K09-12421, K09-12431, K09-12529, K09-12530, K09-12530P, K09-12562P, K09-12610, K09-12610P, K09-12647, K09-12689, K09-12698, K09T-03491C, K09T-09672G, K09T-10728C, K09T-11022C, K09T-11410C, K09T-11796C, K09T-11796D, K09T-11940A, K09T-12624, K10-05097A, K11-01028, K11-01376, K12T-06138A, K12T-07389A, and K12T-08215.
  • 의료기기 분류등급
    General Hospital and Personal Use Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution.
  • 제품 설명
    Custom Fluid Management Set, Sterile, EO, Rx Only || Used to transfer contrast media and saline from a container to a patients || vascular system.
  • Manufacturer
    Merit Medical Systems, Inc.

Manufacturer

Merit Medical Systems, Inc.
  • 제조사 주소
    Merit Medical Systems, Inc., 1600 W Merit Pkwy, South Jordan UT 84095-2416
  • 제조사 모회사 (2017)
    Merit Medical Systems Inc.
  • Source
    USFDA