Events

Device Recall CODMAN CERTAS Programmable Valves 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Codman & Shurtleff, 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
    67793
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1468-2014
  • 사례 시작날짜
    2013-12-13
  • 사례 출판 날짜
    2014-04-17
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2016-04-21
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=126333
  • 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
    Ensuring all customers have the tools to assist in verifying the setting of the valve on x-ray images and the location and orientation of implanted codman certas programmable valves.
  • 조치
    Codman Neuro issued notification packages dated 12/13/13 to Domestic Hospitals and international accounts. Specific letters and associated inclusion of the additional aids, include A) a valve setting verification guide with instructions for use with x-ray images, and B) a plastic valve cut out overlay). A response reply form was included to be completed and returned to confirm effectiveness of the notification.

Device

Device Recall CODMAN CERTAS Programmable Valves
  • 모델명 / 제조번호(시리얼번호)
    All serial numbers
  • 의료기기 분류등급
    Neurological Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Nationwide Distribution.
  • 제품 설명
    CODMAN CERTAS Programmable Valves, central nervous system shunt, models as follows: || 82-8800 In Line Valve Only || 82-8801 In Line Valve with Catheter and Accessories || 82-8802 In Line Valve with Unitized Catheter and Accessories || 82-8803 In line Valve with Unitized BACTISEAL Catheter and Accessories || 82-8804 In Line Valve only with SIPHONGUARD Device || 82-8805 In Line Valve with SIPHONGUARD Device, Catheter and Accessories || 82-8806 In Line Valve with SIPHONGUARD, Unitized Catheter and Accessories || 82-8807 In Line Valve with SIPHONGUARD Device, Unitized BACTISEAL Catheter and Accessories || 82-8850 Certas Therapeutic Management System
  • 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