Events

Device Recall Hemotherm 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Cincinnati Sub-Zero Products LLC 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
    78173
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0629-2018
  • 사례 시작날짜
    2017-11-27
  • 사례 출판 날짜
    2018-02-13
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2018-07-02
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=158835
  • 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
    Controller, temperature, cardiopulmonary bypass - Product Code DWC
  • 원인
    Due to fda's safety communication relating to nontuberculous mycobacteria (ntm) infections related to heater/cooler devices, an updated instructions for use includes a more robust cleaning & disinfection procedure.
  • 조치
    Between November 27, 2017 - December 8, 2017, Cincinnati Sub-Zero Products LLC, distributed Urgent Medical Device Correction notices to their customers via Email and USPS. This Medical Device Correction has been initiated to provide a labeling update to the cleaning & disinfection procedures. The update addresses the disinfection process, cleaning of reusable accessories, as well as clarifying the water type that should be used with the Hemotherm. Customers are encouraged to do the following: 1) Discard your current Hemotherm Operation & Technical Manual and/or Operation Manual. 2) Replace your current Hemotherm Operation & Technical Manual and/or Operation Manual with the enclosed updated Manual(s). For your convenience, all updates have been highlighted in the manuals. " For Hemotherm 400CE users, utilize the P/N 56418-R Operation & Technical Manual and P/N 56075-G Operation Manuals. " For Hemotherm 400MR users, utilize the P/N 56234-S Operation Manual. All customers are encouraged to complete and return the enclosed response form by fax or email to FA2016-009@genthermcsz.com; Fax: 513-772-9119. Customers with questions or concerns, please contact the Field Action Coordinator: Kathy DeSmidt, E-mail: FA2016-009@genthermcsz.com, Phone: 513-772-8810 or 800-989-7373.

Device

Device Recall Hemotherm
  • 모델명 / 제조번호(시리얼번호)
    none
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    US Nationwide Distribution
  • 제품 설명
    Hemotherm¿ Dual Reservoir Cooler/Heater System Models 400CE and 400MR || Product Usage: || A dual reservoir, water re-circulating device that supplies temperature controlled water to a heat exchanger. The device, in conjunction with a heat exchanger, is used to warm or cool the blood that enters and exits a blood heat exchanger for adult, pediatric or infant patients.
  • Manufacturer
    Cincinnati Sub-Zero Products LLC

Manufacturer

Cincinnati Sub-Zero Products LLC
  • 제조사 주소
    Cincinnati Sub-Zero Products LLC, 12011 Mosteller Rd, Cincinnati OH 45241-1528
  • 제조사 모회사 (2017)
    Gentherm, Inc.
  • Source
    USFDA