Device Recall KING LAD SILI CONE 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
    63580
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0420-2013
  • 사례 시작날짜
    2012-11-02
  • 사례 출판 날짜
    2012-11-21
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2013-05-28
  • 사례 출처
    USFDA
  • 사례 출처 URL
  • 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 firm received two complaints from a user facility in new jersey regarding color-coded eto sterilization indicators on the primary device packaging that did not undergo the expected color change. the complainant reported devices that had pink color indicators when the product packaging specified that the color should change from pink to yellow (or brown) if the product had subjected to an eto.
  • 조치
    King Systems sent an URGENT MEDICAL DEVICE RECALL NOTIFICATION letter dated October 31, 2012 to all affected consignees via email. The letter identified affected product, problem and actions to be taken. The letter states that further use and/or distribution of any remaining product affected by this recall should cease immediately. The letter instructs customers to destroy all of the affected products and indicate the destruction by signing and returning the attached forms using the enclosed self-addressed envelope. For questions contact your King Systems customer service representative at 800-642-5464.

Device

  • 모델명 / 제조번호(시리얼번호)
    REF: LAD-304, Lot #K120619
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    US Nationwide Distribution - WI, TX, NY, MO, IN, KY, FL, NJ, PA, TN, and NC
  • 제품 설명
    KING LAD SILI CONE SINGLE USE, King Systems, 10 devices/case, ETO Sterile || Size 4 / Adult Silicone King LAD¿ Patient Size: 50-70kg
  • Manufacturer

Manufacturer

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