Events

Intake/Reservoir Valve (Part No. 875400), used in all sizes of Laerdal Silicone Resuscitators. Responsible firm on the label: Distributed in the U.S. by Laerdal Medical Corporation, Wappingers Falls, NY, Made in Norway. 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Laerdal 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
    28029
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0520-04
  • 사례 시작날짜
    2003-12-23
  • 사례 출판 날짜
    2004-02-10
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2005-11-16
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=31073
  • 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
    Ventilator, Emergency, Manual (Resuscitator) - Product Code BTM
  • 원인
    Potential for the flap valve component of the intake/reservoir valve to become dislodged from its mount, rendering the resuscitator inoperative.
  • 조치
    Letters issued on 1/14/2004. The recall involves the replacement of the Inner Part of the Intake/Reservoir Valve, which is part of the Laerdal Silicone Resuscitator. Recall is to the user level.

Device

Intake/Reservoir Valve (Part No. 875400), used in all sizes of Laerdal Silicone Resuscitators. Re...
  • 모델명 / 제조번호(시리얼번호)
    Lot numbers were not provided. All product shipped after 1/29/2003 is affected. Customers need to visually examine the Intake/Reservoir valve in order to determine if they have affected product.
  • 의료기기 분류등급
    Anesthesiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Product was shipped to approximately 264 customers nationwide, and 3 foreign consignees (Mexico, Brazil and Northern Mariana Islands). Product was also sold to a few exporters who shipped units to unknown countries. Customers include distributors and end users. There were 2,403 parts shipped to Laerdal Medical Canada, Ltd., Toronto, Ontario, Canada. That firm is responsible for conducting an independent recall, reportedly with the knowledge of the Canadian government.
  • 제품 설명
    Intake/Reservoir Valve (Part No. 875400), used in all sizes of Laerdal Silicone Resuscitators. Responsible firm on the label: Distributed in the U.S. by Laerdal Medical Corporation, Wappingers Falls, NY, Made in Norway.
  • Manufacturer
    Laerdal Medical Corporation

Manufacturer

Laerdal Medical Corporation
  • 제조사 주소
    Laerdal Medical Corporation, 167 Myers Corners Rd, Wappingers Falls NY 12590-3827
  • Source
    USFDA