Events

Device Recall CODMAN CERTAS Programmable Valve 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Codman & Shurtleff, Inc. 에 의해 제조된 제품과 관련되어 있습니다.

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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
    65179
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0858-2014
  • 사례 시작날짜
    2013-05-16
  • 사례 출판 날짜
    2014-01-29
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2015-06-02
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=118134
  • 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
    Shunt, central nervous system and components - Product Code JXG
  • 원인
    Codman certas programmable valves used for hydrocephalus may not operate properly.
  • 조치
    Codman issued an Urgent Notice dated May 16, 2013, to all affected customers. The letter identifed the affected product, problem and actions to be taken. Mitigation instructions are provided and if not followed or are not successful, either issue could lead to symptoms associated with under- or over-drainage. Units not implanted are to be returned. A U.S Acknowledgement Form and fax are requested to be completed and faxed to: 1-888-943-4193, or e-mail the form to codman8894@stericycle.com. If you have any questions on concerns in regards to this recall, please contact your Codman Representative or Stericycle at 1-888-943-2395.

Device

Device Recall CODMAN CERTAS Programmable Valve
  • 모델명 / 제조번호(시리얼번호)
    Lot Codes:  CLNCB1 CMBBP1 CMBCPN CMCBWG CMCC2V CMDCN8 CMDDJN CMGB8H CMJCL8 CMJCPW CMKB21 CMMCGR CMNBFB CMNBZJ CMNC8T CMNCYL CMPB4V CNCCPF CNDBCW CNDBRH CNDCJ2 CNFCK7 CNGBG0 CNGBK2 CNHCKH CNHCZN CNJBW5 CNJBWZ CNJC38 CNJC4K CNJCD3 CNJCFR CNJCMN CNKBWP CNKCC8 CNKCL3 CNLBR6 CNLCL3 CNLCW3 CNNCWF CNPB1R CNPBRH CNPCLR CPBC96 CPBCCR CPBCRV CPCBG9 CPCCMK CPDBYC CPDC07 CPDCC7 CNBBCV CNCB6W CNGBRY CNHB95 CNNDCK CNPB1T CNPBML CPBB3G CPCBG8 CPCCBH CPCCM1 CPCCMZ CPFBKP
  • 의료기기 분류등급
    Neurological Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution - US Nationwide, Australia, Austria, Belgium, Brazil, Switzerland, Czech Republic, Germany, Spain, Finland, France, Great Britain, Israel, Italy, Netherlands, Norway, Portugal, Russia, Saudi Arabia, Sweden, Slovenia, Slovakia, Turkey, South Africa, and UK.
  • 제품 설명
    Codman Certas Programmable Valve In Line Valve Only || Product Code: 82-8800 || Product Usage: || The CODMAN CERTAS Programmable Valve is an implantable device that provides constant intraventricular pressure and drainage of CSF (cerebrospinal fluid) for the management of hydrocephalus. The valve can be set to a choice of eight opening pressure settings for constant intraventricular perssure drainage of CSF. The CODMAN CERTAS Therapy Management System (TMS) allows the non-invasive reading or adjustment of the valve setting.
  • Manufacturer
    Codman & Shurtleff, Inc.

Manufacturer

Codman & Shurtleff, Inc.
  • 제조사 주소
    Codman & Shurtleff, Inc., 325 Paramount Drive, Raynham MA 02767
  • 제조사 모회사 (2017)
    Johnson & Johnson
  • Source
    USFDA