Events

Device Recall King LTSD 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
    66189
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0002-2014
  • 사례 시작날짜
    2012-12-13
  • 사례 출판 날짜
    2013-10-01
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2013-11-08
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=121688
  • 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
    On december 13, 2012, king systems initiated a voluntary recall of one (1) case(s) (5) individual products) from one (1) lot [(iv1v3) 62 cases, 310 products]of king ltsd oropharyngeal airways because the package label indicated that the airway was a size 5 when in fact the airway in the package was a size 4. when king manufacturers a lot, all of the components are the same size, part number etc. i.
  • 조치
    King Systems notified the only one (1) consignee who received the affected product of the problem via a customer complaint. Five (5) of the five (5) affected products were destroyed by consignee.

Device

Device Recall King LTSD
  • 모델명 / 제조번호(시리얼번호)
    Part Number(s): KLTSD415 Lot Number(s): IV1V3
  • 의료기기 분류등급
    Anesthesiology Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    USA Nationwide Distribution in the state of NY
  • 제품 설명
    King LTS-D Oropharyngeal Airways || Product Usage: The King LTS-D is intended for use in adult patients (in excess of 25 kg) for controlled ventilation during anesthesia for procedures that are short in duration and when the patient is considered to have a low risk of aspiration of stomach contents.
  • Manufacturer
    King Systems Corp.

Manufacturer

King Systems Corp.
  • 제조사 주소
    King Systems Corp., 15011 Herriman Blvd, Noblesville IN 46060-4253
  • 제조사 모회사 (2017)
    Vsri Holding Ii Aps
  • Source
    USFDA