Events

Device Recall InterX 5002, Sport, 1000, & Personal Sport packaged with Triad Alcohol Wipes 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Neuro Resource Group 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
    58255
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2105-2011
  • 사례 시작날짜
    2011-02-07
  • 사례 출판 날짜
    2011-04-28
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2011-09-23
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=98823
  • 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
    Stimulator, nerve, transcutaneous, for pain relief - Product Code GZJ
  • 원인
    Product package contains alcohol prep pads recalled by triad group because the prep pads have the potential to be contaminated with an objectionable organism.
  • 조치
    Triad Group issued a press release on 2/7/2011, and notified consignees by e-mail 3/2/2011. Neuro Resource Group, Inc. ( NRG ) removed the recalled Triad wipes from all kits in house and obtained non recalled wipes from an alternate supplier. For replacement wipes customers may contact NRG customer service at 1-877-314-6500.

Device

Device Recall InterX 5002, Sport, 1000, & Personal Sport packaged with Triad Alcohol Wipes
  • 모델명 / 제조번호(시리얼번호)
    All lots of the alcohol wipes.
  • 의료기기 분류등급
    Neurological Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution
  • 제품 설명
    Inter x 5002 Device, Inter x Professional Sport Device, Inter x 1000 Personal Device, and Inter x Personal Sport packaged with Triad alcohol wipes. The alcohol wipes manufactured by the Triad Group were labeled under brand names Triad, Select, Select Medical Products, PSS Select or PSS World Medical Inc. || Alcohol wipe is provided as a cleaning convenience for device electrodes.
  • Manufacturer
    Neuro Resource Group Inc

Manufacturer

Neuro Resource Group Inc
  • 제조사 주소
    Neuro Resource Group Inc, 1100 Jupiter Rd Ste 190, Plano TX 75074-7047
  • Source
    USFDA