Events

Device Recall Cloth electrodes with SilverCarbon construction 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 NAImco Inc dba Richmar 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
    63927
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0816-2013
  • 사례 시작날짜
    2009-11-30
  • 사례 출판 날짜
    2013-02-14
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2013-09-03
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=115046
  • 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
    Electrode, cutaneous - Product Code GXY
  • 원인
    Electrode socket terminal pulling away from the electrode lead wire when the electrical stim lead wire was removed.
  • 조치
    Rich-Mar sent "URGENT: MEDICAL DEVICE VOLUNTARY RECALL" letters to affected customers beginning on 11/30/2009. The letter identified the product, problem, and actions to be taken by the customers. Contact the firm at 423-648-7730 ext. 214 for questions relating to t his recall.

Device

Device Recall Cloth electrodes with SilverCarbon construction
  • 모델명 / 제조번호(시리얼번호)
    All Serial Numbers distributed between 11/01/2009 and 01/31/2010
  • 의료기기 분류등급
    Neurological Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Distributed in the states of GA and TN.
  • 제품 설명
    Cloth electrodes with Silver-Carbon construction: || P/N 202-9231, Cat No. 400-899, 2" x 2" Electrode, Cloth, AG, All Serial Numbers distributed between 11/01/2009 and 01/31/2010 || P/N 202-9241, Cat No. 400-895, 2" Round Electrode, Cloth, AG, All Serial Numbers distributed between 11/01/2009 and 01/31/2010 || P/N 202-9381, Cat No. 400-889, 2" x 3.5" Electrode, Cloth AG, All Serial Numbers distributed between 11/01/2009 and 01/31/2010 || P/N 202-9501, Cat No. 202-9501, 1.25" Round Electrode, Cloth AG, All Serial Numbers distributed between 11/01/2009 and 01/31/2010 || P/N 400-8991, Cat Nos.: 400-877T and 400-899T, 2" x 2.25" Electrode, Cloth, AG, All Serial Numbers distributed between 11/01/2009 and 01/31/2010. || Cutaneous electrode.
  • Manufacturer
    NAImco Inc dba Richmar Inc

Manufacturer

NAImco Inc dba Richmar Inc
  • 제조사 주소
    NAImco Inc dba Richmar Inc, 4120 S Creek Rd, Chattanooga TN 37406-1021
  • Source
    USFDA