Device Recall Concept Lemon Scented Disinfectant Deodorant 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 ITW Dymon 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
    31174
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1407-05
  • 사례 시작날짜
    2005-02-15
  • 사례 출판 날짜
    2005-08-30
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2008-03-12
  • 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
  • 원인
    Failed epa required efficacy testing; may not perform as intended.
  • 조치
    Telephone calls were initiated to the direct accounts on 2/15/05 and by letter initiated 2/21/05 requesting return of the product and subrecall by the direct account, unless the direct account preferred the recalling firm to conduct the subaccount recall. The recall was later expanded and recall letters dated 4/29/05 were issued requesting the same information as the initial letter.

Device

  • 모델명 / 제조번호(시리얼번호)
    Initially recalled lot number: Private label - A66241;  Expanded recalled lot numbers: Private label - A23141 and A28141
  • 유통
    Distribution was nationwide to wholesalers and own-label distributors.
  • 제품 설명
    ITW Dymon Medaphene Plus Lemon Disinfectant Spray, Pseudomonacidal, Virucidal, Mildewcidal, Fungicidal, Staphylocidal, Tuberculocidal, packaged in 20-oz. steel aerosol cans, net wt. 16 oz (1 lb), 12 cans/case, containing 0.19% o-phenylphenol and 68.00% ethyl alcohol, Product #52820. The firm name on the label is ITW Dymon, Olathe, KS. || The product is also distributed under the following private labels: || (1) Renown Lemon Disinfectant Deodorant, Distributed by AmSan, LLC, Deerfield, IL; || (2) Concept Lemon Scented Disinfectant Deodorant, Product 5282057750, Sold By Manny''s Sanitary Supplies, Inc., New Orleans, LA.
  • Manufacturer

Manufacturer

  • 제조사 주소
    ITW Dymon, 805 E Highway 56, Olathe KS 66061-4914
  • Source
    USFDA