Events

Device Recall King LT(S)D Oropharyngeal Airway 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 King Systems Corp. 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
    57810
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1879-2011
  • 사례 시작날짜
    2011-01-24
  • 사례 출판 날짜
    2011-04-04
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-06-29
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=97483
  • 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
    Airway, oropharyngeal, anesthesiology - Product Code CAE
  • 원인
    The firms contract manufacturer reported that the products were below the specification for hardness. this could contribute to a higher incidence of problems during the insertion and final positioning of the airway in the patient. in rare instances the softness of the tube could cause the tube to fold over.
  • 조치
    King Systems Corp. sent an URGENT DEVICE RECALL NOTICE letter dated January 24, 2011, to all affected consignees. The letter identified the product, the problem, and the action to be taken by the customer. The letters instructed users to cease all sales of the recalled product, to notify the consignees for any product that was further distributed, and to return all recalled product to King Systems. The notice did include a response form. For questions call 317-776-6823, ext 257.

Device

Device Recall King LT(S)D Oropharyngeal Airway
  • 모델명 / 제조번호(시리얼번호)
    201011-169
  • 의료기기 분류등급
    Anesthesiology Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA and Canada
  • 제품 설명
    King System , King LTS-D Kit Size 5, Sterile, REF KLTSD405, Manufacturer: King Systems Noblesville, IN. || Ventilation during anesthesia during procedures of short duration. An oropharyngeal airway is a device inserted through the mouth to provide a patent airway.
  • Manufacturer
    King Systems Corp.

Manufacturer

King Systems Corp.
  • 제조사 주소
    King Systems Corp., 15011 Herriman Blvd, Noblesville IN 46060
  • 제조사 모회사 (2017)
    Vsri Holding Ii Aps
  • Source
    USFDA