Events

Device Recall APPARATUS, SUCTION, WARD USE, PORTABLE, ACPOWERED 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
    79190
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0973-2018
  • 사례 시작날짜
    2017-08-31
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2018-06-13
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=161566
  • 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, suction, ward use, portable, ac-powered - Product Code JCX
  • 원인
    A shipment of lcsu 4 suction units and canisters attempted importation into the united states but was refused by fda for lack of necessary approvals with cdrh by the foreign firms.
  • 조치
    On September 5, 2017, a letter was mailed to customers notifying them that they received one of the units subject to recall. The letter requested that the customer return the affected item for a replacement. Questions or concerns can be directed to 1-877-523-7325 or email: customerservice@laerdal.com , referencing the following number: 2017-R-05.

Device

Device Recall APPARATUS, SUCTION, WARD USE, PORTABLE, ACPOWERED
  • 모델명 / 제조번호(시리얼번호)
    Affected SNs between: 170401A0001 and 170401A0270
  • 의료기기 분류등급
    General and Plastic Surgery Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationally
  • 제품 설명
    LCSU 4, Laerdal Compact Suction Unit || The LCSU 4 is a portable, electrically powered, medical suction device intended for field and transport use. It is intended for intermittent operation to remove secretions, blood or vomit from a patient s airway to allow ventilation. Higher vacuum levels are generally selected for oropharyngeal suction, and lower vacuum levels are usually selected for tracheal suctioning and the suctioning of children and infants.
  • Manufacturer
    Laerdal Medical Corporation

Manufacturer

Laerdal Medical Corporation
  • 제조사 주소
    Laerdal Medical Corporation, PO Box 1840, 167 Myers Corners Rd, Wappingers Falls NY 12590-3869
  • 제조사 모회사 (2017)
    Laerdal Medical Corporation
  • Source
    USFDA