Events

Device Recall Atrium Medical Ocean Water Seal Chest Drain ATS 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Atrium Medical Corporation 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
    66788
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0738-2014
  • 사례 시작날짜
    2013-11-19
  • 사례 출판 날짜
    2014-01-14
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2015-06-11
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=123494
  • 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
    Apparatus, autotransfusion - Product Code CAC
  • 원인
    Chest drain tubing of of the ats blood recovery may leak or disconnect.
  • 조치
    Atrium Medical issued notification letters to direct consignees by UPS next day on 19 November 2013, and indirect consignees (distributors customers) by UPS next day or USPS priority (for customers with a PO Box) on 27 November 2013. The Letter explain the issue and the steps that should be taken. The customer will be offered replacement with unaffected product or credit. The firm describes Procedures for Emergency Use. The firm identifies potential product substitutions. These products are the same drainage product without the auto-transfusion line. International Distributors. International distributors provided with the Recall Authorization' package and the customer letter. Accounts are requested to complete the Recall Reply Form acknowledging receipt of the notification. Contact Atrium Medical Customer Service at 1-800-370-7899, Monday through Friday between 9:00 am to 5:00 pm.

Device

Device Recall Atrium Medical Ocean Water Seal Chest Drain ATS
  • 모델명 / 제조번호(시리얼번호)
    Lot number starting with 10883097 and the ending lot number 10913346. (All units in between and including these two numbers)
  • 의료기기 분류등급
    Anesthesiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution-USA (nationwide) and the countries of Australia, Canada, Austria, Ireland, Romania, South Africa, Colombia, Lebanon Netherlands, Jordan, Russia, and Taiwan.
  • 제품 설명
    Atrium Ocean Water Seal Chest Drain ATS (Autotransfusion) Blood Recovery System Dual patient lines with stopcock and in-line connectors || Product Code: 2052-000. || To evacuate air and/or fluid from the chest cavity or mediastinum.
  • Manufacturer
    Atrium Medical Corporation

Manufacturer

Atrium Medical Corporation
  • 제조사 주소
    Atrium Medical Corporation, 5 Wentworth Dr, Hudson NH 03051-4929
  • 제조사 모회사 (2017)
    Getinge AB
  • Source
    USFDA