Events

SteriProbe Temperature Probe 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Cincinnati Sub-Zero Products 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
    60307
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0372-2012
  • 사례 출판 날짜
    2012-01-11
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2013-08-13
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=105007
  • 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
    temperature probe - Product Code BZT
  • 원인
    Reports that the rectal/ esophageal temperature probes are not reading correctly. this situation causes the blanketrol device, which the probes connect to, to shut down operation and display a 'check probe' error.
  • 조치
    Cincinnati Sub-Zero Products, Inc., issued an "Urgent Medical Device Field Action" letter on November 1, 2011 to all affected customers. The letter includes; description of product and problem, and a list of the affected lot numbers. The letter instructs the customers to discontinue use of the device. All unused product is to be returned to the Biomedical/Clinical Engineering and/or Service Department for an replacement and all used probes are to be disposed of in accordance with hospital policy. The customers are also instructed to complete and return an attached Recall Response Form ASAP. For additional information, customers may contact the Beatrice Washington at 1-800-989-7373 or (513) 772-8810.

Device

SteriProbe Temperature Probe
  • 모델명 / 제조번호(시리얼번호)
    The following lot codes are subject to recall: 12998, 12999, 19257, 19257A, 19644, 21536, 21537, 27446, 29112, 31081, 31082, 32209, 37281, 38522,  8996, D414723, D416607, D420120, D421702, D423801, D423908, D525212, D515408, D516607, D517108, D520709, D524107, D525502, D527632, D530518, D624011, D624012, D634834 D706611, D709119, D720450, D721118, D722015, and D727416.
  • 의료기기 분류등급
    Anesthesiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide distribution and Canada.
  • 제품 설명
    Cincinnati Sub Zero, Steri-Probe Temperature Probe, Esophageal/Rectal Temperature Probe, Part Number: 39622, Catalog #491B. TA disposable temperature probe used in conjunction with a measuring/monitoring device to continuously measure/monitor a patient's core body temperature.
  • Manufacturer
    Cincinnati Sub-Zero Products Inc

Manufacturer

Cincinnati Sub-Zero Products Inc
  • 제조사 주소
    Cincinnati Sub-Zero Products Inc, 12011 Mosteller Rd, Cincinnati OH 45241
  • 제조사 모회사 (2017)
    Gentherm, Inc.
  • Source
    USFDA