Events

INFINITY DUAL HEMO MCable Pod 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Draegar Medical Systems, 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
    79209
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0942-2018
  • 사례 시작날짜
    2017-10-04
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2018-06-15
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=161659
  • 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
    Monitor, physiological, patient(with arrhythmia detection or alarms) - Product Code MHX
  • 원인
    Dual hemo mcable pods with revision index (ri) 15 and 16, which are used with the dr¿ger infinity acute care system, may permit liquid ingress inconsistent with their ipx4 rating, which could potentially result in an incorrect measured value of invasive blood pressure.
  • 조치
    In September of 2017 an Urgent medical Device Recall letter was issued to customers informing them of the recall and to request that inventory be checked to see if the product subject in the recall is on the premises. To do this, the customer will check the label for the revision index number which is located on the upper middle portion of label. RI number 15 and 16 are included in the recall. No other numbers are subject to recall. Affected product will receive a sleeve from the company to correct the issue. Questions or concerns can be directed to 1-800-437-2437 (Press 1, then press 32349) or contact Customer Care at 1-800-437-2437 (Press 4, then press 4 again)

Device

INFINITY DUAL HEMO MCable Pod
  • 모델명 / 제조번호(시리얼번호)
    Have the affected revision indexes: 15 or 16 (found on the product label)
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationally
  • 제품 설명
    INFINITY DUAL HEMO MCable Pod
  • Manufacturer
    Draegar Medical Systems, Inc.

Manufacturer

Draegar Medical Systems, Inc.
  • 제조사 주소
    Draegar Medical Systems, Inc., 6 Tech Dr, Andover MA 01810-2434
  • 제조사 모회사 (2017)
    Stefan Dräger GmbH
  • Source
    USFDA