Events

Integra Licox Test Kit 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Integra LifeSciences 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
    68159
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1675-2014
  • 사례 시작날짜
    2014-04-16
  • 사례 출판 날짜
    2014-05-30
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2014-10-24
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=127071
  • 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
    Device, monitoring, intracranial pressure - Product Code GWM
  • 원인
    Integra lifesciences has identified through a small number of complaints that some lot numbers of licox test kits (catalog number bc10r) may provide erroneous "calibration test failure" message when they are used with the licox pto2 monitor (lcso2, or may provide an erroneous out of range result with the licox cmp brain tissue oxygen and temperature monitor (ac31).
  • 조치
    Integra sent an "Urgent Voluntary Medical Device Recall/Return Response form notifications dated April 16, 2014 to US customers via traceable courrier service and to non-US customers via traceable email or facsimile. The customer notification advises them of the nature of the issue and the potential for adverse patient consequences; advises them to review their inventory and if they have BC10R Test Kit Resistors with an affected lot number to immediately stop using it; requests they identify and report to Integra if they do or do not have any affected BC10R affected lot numbers; and advises them how to return any affected products in their possession. Customers with questions were instructed to call 1-855-532-1723.

Device

Integra Licox Test Kit
  • 모델명 / 제조번호(시리얼번호)
    Catalog Number BC10R Lot Nos: 051113, 100913, 140513, 161013, 25013
  • 의료기기 분류등급
    Neurological Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA including Illinois, Florida, Maryland, Massachusetts, North Carolina, Pennsylvania, South Dakota and Internationally to Australia, Austria, Belgium, Chile, Finland, Germany, Great Britain, Greece, Israel, Italy and Russia.
  • 제품 설명
    Integra Licox Test Kit REF BC10R Rx Only || An accessory provided for use with the LCXO2 and AC31 PtO2 Monitors. It provides users with a secondary means to verify the monitor's PtO2 state-of-calibration (but does not provide calibration) when needed by providing a specific electrical signal to the monitor.
  • Manufacturer
    Integra LifeSciences Corp.

Manufacturer

Integra LifeSciences Corp.