ITW Dymon Medaphene Plus 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 34720. The firm name on the label is ITW Dymon, Olathe, KS. || The product is also sold under the following private labels: || (1) Renown Disinfectant Deodorant II, Product REN05013, Distributed by AmSan, LLC, Deerfield, IL; || (2) Decon Aerosol Disinfectant, Catalog #8617, Manufactured For Decon Labs, Inc., Bryn Mawr, PA; || (3) New Jax Medaphene Plus Disinfectant Spray, Sold By Newell Paper Company, Hattiesburg, MS, Columbus, MS, Meridian, MS; || (4) San-O-Phene Plus Disinfectant Spray, Sold By San Joaquin Supply Co., Fresno, CA; || (5) Sterling Quality Hospital Use Micro II Disinfectant Spray, Distributed By Sterling Sanitary Supply Corporation, Woodside, NY; || (6) Ball-Phene Spray Disinfectant, Reorder #3U037, Manufactured for W.W. Grainger, Inc., Lake Forest, IL; || (7) Area Two-In-One Disinfectant Spray Original, Sold By Area Distributors, Inc., Quincy, IL; || (8) Benefax Disinfectant Spray, Exclusively Sold By Biotek Corporation, Melrose Park, IL; || (9) Pheno-Cen Spray Disinfectant/Deodorant, Sold By Central Solutions, Inc., Kansas City, KS; || (10) Clark Bio-Phene Plus Disinfectant/Spray, Sold By Clark Paper Plus Inc., Carteret, NJ; || (11) LOGIChem Hosp-I-Septic Disinfectant Spray, Distributed Exclusively For Edmar, Woodside, NY; || (12) Morcept Hospital Disinfectant, Sold By Moore Research, Inc., St. Louis, MO; || (13) Pro Chem Deocept Purity Hospital Disinfectant, Sold By Pro-Chem, Inc., Alpharetta, GA; || (14) Select Specialty Products Spectrum II Hospital Type Disinfectant, Sold By Select Specialty Products, Charlottesville, VA. 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-1405-05
  • 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 - A56241, A56242, and A87242; private labels - A17241, A27241, A30141, A31141, A31142, A75241, A85241, A85244, A57241, A57242, A87241, A95241, and A99041;   Expanded recall lot numbers:  ITW Dymon brand - A84141, A84142, A18143, A98141, A09141, A09142, A80342, A90341, A14342, A14343, A66341, and A66342; private labels - A91141, A91142, A23141, A74141, A84141, A65141, A65142, A65143, A18141, A18142, A18143, A98141, B89141, B89142, A60241, A80241, A80242, A21241, A91241, A91242, A85242, A85243, A49241, A59241, A59242, A70341, A80341, A80342, A61341, A71341, A71342, A82341, A83341, A14341, A14342, A55341, A55342, A56341, A56342, A66341, A70051, A01051, A81051, A13051, and A13052.
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Distribution was nationwide to wholesalers and own-label distributors.
  • 제품 설명
    ITW Dymon Medaphene Plus 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 34720. The firm name on the label is ITW Dymon, Olathe, KS. || The product is also sold under the following private labels: || (1) Renown Disinfectant Deodorant II, Product REN05013, Distributed by AmSan, LLC, Deerfield, IL; || (2) Decon Aerosol Disinfectant, Catalog #8617, Manufactured For Decon Labs, Inc., Bryn Mawr, PA; || (3) New Jax Medaphene Plus Disinfectant Spray, Sold By Newell Paper Company, Hattiesburg, MS, Columbus, MS, Meridian, MS; || (4) San-O-Phene Plus Disinfectant Spray, Sold By San Joaquin Supply Co., Fresno, CA; || (5) Sterling Quality Hospital Use Micro II Disinfectant Spray, Distributed By Sterling Sanitary Supply Corporation, Woodside, NY; || (6) Ball-Phene Spray Disinfectant, Reorder #3U037, Manufactured for W.W. Grainger, Inc., Lake Forest, IL; || (7) Area Two-In-One Disinfectant Spray Original, Sold By Area Distributors, Inc., Quincy, IL; || (8) Benefax Disinfectant Spray, Exclusively Sold By Biotek Corporation, Melrose Park, IL; || (9) Pheno-Cen Spray Disinfectant/Deodorant, Sold By Central Solutions, Inc., Kansas City, KS; || (10) Clark Bio-Phene Plus Disinfectant/Spray, Sold By Clark Paper Plus Inc., Carteret, NJ; || (11) LOGIChem Hosp-I-Septic Disinfectant Spray, Distributed Exclusively For Edmar, Woodside, NY; || (12) Morcept Hospital Disinfectant, Sold By Moore Research, Inc., St. Louis, MO; || (13) Pro Chem Deocept Purity Hospital Disinfectant, Sold By Pro-Chem, Inc., Alpharetta, GA; || (14) Select Specialty Products Spectrum II Hospital Type Disinfectant, Sold By Select Specialty Products, Charlottesville, VA.
  • Manufacturer

Manufacturer

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