Events

Licox Brain PMO Probe Kit; for Cerebral Pressure, Ref IP2.P; 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
    56820
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0161-2011
  • 사례 시작날짜
    2010-09-15
  • 사례 출판 날짜
    2010-10-28
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-04-18
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=94583
  • 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
    Incorrect expiration date - the outer boxes of the ip2p licox complete kit for cerebral pressure, temperature and icp monitoring probes, lot 250210a are labeled with an incorrect shelf life date (10 months too long).
  • 조치
    Integra issued Urgent Product Recall Notification letters dated September 16, 2010 to US customers and foreign consignees, identifying the affected lots and actions to be taken by customers. Affected product is not to be further distributed and should be quarantined pending return to the firm. Customers and Distribors should contact Integra Customer Service for a Returned Material Authorization Number, and then return the product to the Distribution Center. In addition, a Recall Acknowledgement and Return Form is to be completed and returned. Customers can contact Integra at 609 936-2495.

Device

Licox Brain PMO Probe Kit; for Cerebral Pressure, Ref IP2.P;
  • 모델명 / 제조번호(시리얼번호)
    Ref IP2P, Lot number: 250210A; Serial Numbers: 833, 834, 835, 836, 837, 838, 839, 841, 844, 846, 847, 848, 850, 851, 852, 853, 854, 855, 857, 858, 859, 860, 861, 862, 864.
  • 의료기기 분류등급
    Neurological Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution: USA, including the states of FL, ID, IL, and NJ, and the countries of Argentina and Costa Rica.
  • 제품 설명
    Licox Brain PMO Probe Kit; || Ref IP2.P; || Multiparameter Monitoring Oxygen + ICP Channel: Contain Products: REF IP2 Bolt kit for 2 brain probes, Ref CC1.P1 combined Oxygen & Temperature probe; || Contains sterile and non-pyrogenic if package is unopened and undamaged. || Integra US, 311 Enterprise Drive, Plainsboro, NJ 08536
  • Manufacturer
    Integra LifeSciences Corp.

Manufacturer

Integra LifeSciences Corp.