ITW Dymon Medaphene Plus Orange 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 52920. The firm name on the label is ITW Dymon, Olathe, KS. || The product is also distributed under the following private labels: || (1) O.D.S. Orange Disinfectant Spray, Continental Research Corporation, St. Louis, MO; || (2) Drummond American Bristol Orange Disinfectant Spray, Product DR8561, Sold by Drummond American Corporation, Vernon Hills, IL; || (3) Romaine Medaphene Plus Disinfectant Spray Orange Fragrance, Manufactured For Romaine Companies, Tulsa, OK, Newburgh, IN, and Hopkinsville, KY; || (4) State Discover Aerosol Disinfectant Citrus, Stock #109566 and #109567, Sold By State Industrial Products, Cleveland, OH; || (5) Medisan Disinfectant Spray, Orange Scent, Distributed by Cape Janitor Supply, Cape Girardeau, MO; || (6) DETCO Industries Germ Defense Disinfectant Spray, Orange Fragrance, Sold by DETCO Industries, Conway, AR; || (7) Orange Disinfectant Spray, Manufactured for MASSCO, Inc., Norwood, MA; || (8) Meyer Tri Power, Sold By Meyer Laboratory Inc., Blue Springs, MO; || (9) Orange Surfacidal Disinfectant Spray, Packed for Check Mark, A Division of DM Resources, Inc., Irving, TX; || (10) Citrus-Cidal Disinfectant Spray, Orange Fragrance, Sold By navy brand Manufacturing Company, St. Louis, MO; || (11) Pro Chem Deocept Citra Disinfectant Spray, Orange Fragrance, Sold By Pro-Chem, Inc., Alpharetta, GA; || (12) Ricmar Industries Tang-I-Cide Tangerine Fragrance Disinfectant, Sold Exclusively By Ricmar Industries, Inc., Elmhurst, IL; || (13) Neutron NI-712 Disinfectant Spray, Stock #104787, A product of Neutron Industries, Phoenix, AZ. 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-1406-05
  • 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
    Disinfectant, Medical Devices - Product Code LRJ
  • 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 numbers:  ITW Dymon brand - A66244 and A58241; private labels - A66241, A66243, A66244, A87241, and A58241.  Expanded recalled lot numbers:  ITW Dymon brand - A96141, A88241, A00341, A10341, A24342, A24343, A25341; private labels - A81141, A81142, A91141, A91142, A02141, A02142, A23141, A94141, A65141, A28141, A09141, A19141, A19142, A90241, A90242, A21241, A21242, A32241, A42241, A66242, A88241, A00341, A61341, A42341, A72341, A24341, A24342, A25341, A56341, A01051, A01052, A01053, A11051, A81051, A21051, A82051, A23051, and A23052.
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Distribution was nationwide to wholesalers and own-label distributors.
  • 제품 설명
    ITW Dymon Medaphene Plus Orange 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 52920. The firm name on the label is ITW Dymon, Olathe, KS. || The product is also distributed under the following private labels: || (1) O.D.S. Orange Disinfectant Spray, Continental Research Corporation, St. Louis, MO; || (2) Drummond American Bristol Orange Disinfectant Spray, Product DR8561, Sold by Drummond American Corporation, Vernon Hills, IL; || (3) Romaine Medaphene Plus Disinfectant Spray Orange Fragrance, Manufactured For Romaine Companies, Tulsa, OK, Newburgh, IN, and Hopkinsville, KY; || (4) State Discover Aerosol Disinfectant Citrus, Stock #109566 and #109567, Sold By State Industrial Products, Cleveland, OH; || (5) Medisan Disinfectant Spray, Orange Scent, Distributed by Cape Janitor Supply, Cape Girardeau, MO; || (6) DETCO Industries Germ Defense Disinfectant Spray, Orange Fragrance, Sold by DETCO Industries, Conway, AR; || (7) Orange Disinfectant Spray, Manufactured for MASSCO, Inc., Norwood, MA; || (8) Meyer Tri Power, Sold By Meyer Laboratory Inc., Blue Springs, MO; || (9) Orange Surfacidal Disinfectant Spray, Packed for Check Mark, A Division of DM Resources, Inc., Irving, TX; || (10) Citrus-Cidal Disinfectant Spray, Orange Fragrance, Sold By navy brand Manufacturing Company, St. Louis, MO; || (11) Pro Chem Deocept Citra Disinfectant Spray, Orange Fragrance, Sold By Pro-Chem, Inc., Alpharetta, GA; || (12) Ricmar Industries Tang-I-Cide Tangerine Fragrance Disinfectant, Sold Exclusively By Ricmar Industries, Inc., Elmhurst, IL; || (13) Neutron NI-712 Disinfectant Spray, Stock #104787, A product of Neutron Industries, Phoenix, AZ.
  • Manufacturer

Manufacturer

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