Events

Device Recall King systems 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
    70610
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1361-2015
  • 사례 시작날짜
    2015-02-17
  • 사례 출판 날짜
    2015-04-01
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2015-10-27
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=134354
  • 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
    Connector, airway (extension) - Product Code BZA
  • 원인
    Product is mislabeled as double swivel connector with suction port and is actually double swivel connector without suction port. if the incorrect component is not identified prior to clinical use, the incorrect connector would be replaced during the case without risk to the patient and could result in a short delay of the procedure.
  • 조치
    Kingsystems sent an Urgent Medical Device Recall letter dated February 17, 2015 to affected customers. The letter identified the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. For questions, call your King Systems customer service representative at 800.642.5464.

Device

Device Recall King systems
  • 모델명 / 제조번호(시리얼번호)
    Part number 7169 Lot number 1737171
  • 의료기기 분류등급
    Anesthesiology Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    US Nationwide in the states of IL, IN, KY, MI, PA, and TN
  • 제품 설명
    Double Swivel Connector with Suction Port || Connector, Airway (Extension) || King Systems part 7169 || Product Usage: || An airway connector is a device intended to connect a breathing gas source to a tracheal tube, tracheostomy tube, or gas mask. The double swivel connector with suction port is an optional connector for a breathing circuit. King System s offers two versions of the double swivel connector, one with a suction port and one without a suction port. The clinical significance of the suction port is that it provides the caregiver the opportunity to perform a secondary procedure if so desired.
  • 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