Events

Device Recall NAMIC (TM) Convenience Kit 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Navilyst Medical, 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
    70322
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1154-2015
  • 사례 시작날짜
    2015-01-09
  • 사례 출판 날짜
    2015-02-26
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2017-03-10
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=133388
  • 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
    Cardiovascular procedure kit - Product Code OEZ
  • 원인
    The labelled expiration dating of the affected product is not fully supported by shelf life verification testing, which may result in a sterility breach. use of a fluid management convenience kit, where sterility has been breached, may result in an increased risk of infection.
  • 조치
    Navilyst Medical sent an Urgent Medical Device Recall Notification letter dated January 9, 2015 to US customers (end users) via Federal Express. On January 20, 2015, Recall Notification Packages were sent via Federal Express to 2 International consignees (distributors). the letter identified the affected product, problem and actions to be taken. Customers are instructed to: " Immediately remove the recall product from your inventory (whether in labs, Central Supply, Shipping and Receiving or ANY other location). " Segregate this product in a secure location for return to Navilyst Medical. " Immediately forward a copy of this recall notification to all sites to which you have distributed affected product. " Complete and return the Reply Verification Tracking Form.

Device

Device Recall NAMIC (TM) Convenience Kit
  • 모델명 / 제조번호(시리얼번호)
    Lots 4606270, 4612210, 4616194, 4617867, 4623170, 4641411, 4649602, 4653594, 4655245, 4661836, 4663939, 4665119, 4666347, 4671948, 4672567, 4680203, 4690158, 4690850, 4701000, 4704036, 4704366, 4712691, 4717116,  4719844, 4729019, 4729020, 4771553, 4780273, 4797512, 4805753, 4809347, 4821812, 4831367.
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US Nationwide and the countries of: Canada, and Guam.
  • 제품 설명
    NAMIC Convenience Kit, 3 VALVE KIT CARDIOVASCULAR PROCEDURE KIT, UPN H749600403131, REF/Catalog No. 60040313, STERILE, Rx ONLY --- --- For single use only. --- Device Listing Number D136588. || Product Usage: || NAMIC Convenience Kits are intended to be used in Fluid Management and/or Invasive Pressure Monitoring Systems.
  • Manufacturer
    Navilyst Medical, Inc

Manufacturer

Navilyst Medical, Inc
  • 제조사 주소
    Navilyst Medical, Inc, 10 Glens Falls Technical Park, Glens Falls NY 12801
  • 제조사 모회사 (2017)
    Navilyst Medical, Inc
  • Source
    USFDA