Events

Device Recall King Systems KLTSD414 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
    66869
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0709-2014
  • 사례 시작날짜
    2013-12-13
  • 사례 출판 날짜
    2014-01-10
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2014-05-15
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=124329
  • 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
    Kltd214 airways found inside kltsd414 packages. the kltsd414 airway has a lumen for use of a gastric suction tube; the kltd214 airway does not include a lumen for a gastric suction tube.
  • 조치
    December 13, 2013 Urgent Recall Notices were sent to all Direct Accounts identifying the recalled item, risks associated with the incorrectly labeled product and asking customers to stop use, quarantine and destroy any recalled product on hand. Customers were asked to froward the notifcation if the product was further distributed and FAX the completed recall acknowledgement form to 317-776-5175 or email wnethercutt@kingsystems.com. Call the customer service representative (800.262.8673) to arrange for credit of your affected product(s).

Device

Device Recall King Systems KLTSD414 airway
  • 모델명 / 제조번호(시리얼번호)
    Lot Number(s): I15LB
  • 의료기기 분류등급
    Anesthesiology Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Distributed in the states of CA, NY
  • 제품 설명
    King Systems || KLTSD414 || Quantity, 5 PER CASE KING LTSD || KIT SIZE 4 || King LT(S)-DTM || supraglottic airway || Identification Part Number(s): KLTSD414 || KING LTSD KIT/KIT/TROUSSE/KIT SIZE 4 || Contents: 1 - KLTSD Size 4......(155 - 180cm) .. 1 - 60cc Syringe 1 - Sterile || Lubricant 32-5332 05/10 || Intended for use in adult patients (in excess of 25 kg) for controlled ventilation during anesthesia for procedures that are short in duration.
  • 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