UROS AUTOMATED URINE OUPTUT AND TEMPERATURE MONITOR 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 C.R. Bard, 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
    78231
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0488-2018
  • 사례 상황
    Open, Classified
  • 사례 국가
  • 사례 출처
    USFDA
  • 사례 출처 URL
  • 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
    Urinometer, electrical - Product Code EXS
  • 원인
    The possibility exists that use of the uros automated urine output and temperature monitor may lead to the loss of urine output measurement data and/or urine output measurement inaccuracies resulting in an impact on clinical treatment decisions.
  • 조치
    The firm, Bard Medical Division, sent an "URGENT: MEDICAL DEVICE PRODUCT RECALL" letter dated September 29, 2017 to their consignee. The letter described the product, problem and actions to be taken. The consignee was instructed to immediately examine your inventory and quarantine product; do not use or further distribute any affected product; complete and return the Recall & Effectiveness Check Form by fax to 1-770-784-6460 or email a scanned copy to BMD.FieldAction@crbard.com, Attn: Recall Coordinator, even if you do not have any affected product and return the product. If you have affected product, please contact the BMD Customer Service via phone at 1-800-526-4455 option 5 and again option 5 or email BMD.FieldAction@crbard.com to obtain a Return Goods Authorization number (RGA #). If you have any questions, contact the Senior Director, Quality Systems & Field Assurance at 770-784-6913 or email: Brenda.Sheikey@crbard.com or BMD Customer Service at 1-800-526-4455.

Device

  • 모델명 / 제조번호(시리얼번호)
    Catalog/PC #BK10001M
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    US Distribution to the state of: FL
  • 제품 설명
    BARD(R) UROS(TM) AUTOMATED URINE OUPTUT AND TEMPERATURE MONITOR, MODEL BK10001M || The Uros(TM) Automated Urine Output and Temperature Monitor is indicated to monitor urine output and core bladder temperature.
  • Manufacturer

Manufacturer