Events

Device Recall LHB, Perishable Items Pack Type I 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Lighthouse For The Blind 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
    64776
  • 사례 위험등급
    Class 3
  • 사례 연번
    Z-1089-2013
  • 사례 시작날짜
    2013-03-22
  • 사례 출판 날짜
    2013-04-10
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2013-11-25
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=117026
  • 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
    First Aid Kit with drug - Product Code LRR
  • 원인
    The product contains an iodine 10% ampule (10% povidone iodine swab) which is being recalled by the firm's distributor. the labeling of the iodine 10% ampule labels state that the contents of the package are sterile and does not clarify that this sterility claim is only applicable to the applicator. the antiseptic solution that is applied to the skin is a cutaneous disinfectant, and is not sterili.
  • 조치
    The firm sent "URGENT DEVICE RECALL" letters dated March 22, 2013 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Contact the firm at 800-542-3697 for questions regarding this notice.

Device

Device Recall LHB, Perishable Items Pack Type I
  • 모델명 / 제조번호(시리얼번호)
    All kits shipped between 1/12010 through 3/4/2013.
  • 의료기기 분류등급
    General and Plastic Surgery Devices
  • 의료기기 등급
    Not Classified
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution including DC and the states of AK, AL, AR, AZ, CA, CO, DE, FL, GA, ID, IL, IN, KS, KY, MI, MD, MN, MO, MT, NC, NJ, NM, NY, NV, OH, OK, PA, SC, TN, TX, UT, VA, WA and WY.
  • 제품 설명
    LHB, Perishable Items Pack Type I , Kit Number: 2114002-100. || First Aid Kit.
  • Manufacturer
    Lighthouse For The Blind

Manufacturer

Lighthouse For The Blind
  • 제조사 주소
    Lighthouse For The Blind, 10440 Trenton Ave, Olivette MO 63132-1223
  • 제조사 모회사 (2017)
    Lighthouse For The Blind
  • Source
    USFDA