Events

NORMOFLO H1100 Irrigation Fluid Warmers 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Smiths Medical ASD, 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
    76190
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1105-2017
  • 사례 시작날짜
    2016-10-25
  • 사례 출판 날짜
    2017-01-26
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2017-07-25
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=152491
  • 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
    Warmer, irrigation solution - Product Code LHC
  • 원인
    Smiths medical became aware that that one (1) normoflo¿ h-1100 irrigation fluid warmers was incorrectly labelled with spanish language labels instead of english labels. specifically five (5) labels were incorrect; the operators manual, outer base box label, pole assembly box label, and two (2) o-ring lube labels.
  • 조치
    Consignee were hand delivered a Smiths Medical Urgent Medical device Filed Safety Notice letter dated October 25, 2016. The letter described the Reason for Field Corrective Action, Risk to Health, and Instructions to Customers. Advised consignees to Provide the device to the Smiths Medical Representative who delivered this notice to you. The Smiths Medical Representative will replace the labeling on the device and packaging, and provide you with the correct English language Operators Manual. Complete the Recall Confirmation Form and return it to Smith Medical via e-mail to FCA.Response@Smiths-medical.com. For questions regarding this notification, please ask the Smiths Medical Representative who delivered the notification or contact Smiths Medical Customer Service Department at +46 859477250.

Device

NORMOFLO H1100 Irrigation Fluid Warmers
  • 모델명 / 제조번호(시리얼번호)
    S105B0061
  • 의료기기 분류등급
    General Hospital and Personal Use Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Distribution in the foreign country of Sweden
  • 제품 설명
    NORMFlow H-110 Irrigation Fluid Warmer, Continental Europe, Model H-1100, Reorder H-1100-INT-230. || Product Usage: || NORMOFLO¿ H-1100 Irrigation Fluid Warmers has been designed for safe, in-line warming of irrigating fluids as they are administered to patients. The Fluid Warmer utilizes a solution reservoir housed in a controller unit (warmer). The recirculation solution is heated to present temperature in the reservoir, pumped though a heat exchanger ( a component of the Sets) and is returned to the reservoir for continuous recirculation. The NORMOFLO Warming products are typically used in clinical situations that may require rapid irrigation with warmed fluids.
  • Manufacturer
    Smiths Medical ASD, Inc.

Manufacturer

Smiths Medical ASD, Inc.
  • 제조사 주소
    Smiths Medical ASD, Inc., 1265 Grey Fox Rd, Saint Paul MN 55112-6929
  • 제조사 모회사 (2017)
    Smiths Group Plc
  • Source
    USFDA