Events

Rappel de ITW Dymon Medaphene Plus Country Garden 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 #42620. The firm name on the label is ITW Dymon, Olathe, KS. || The product is also distributed under the following private labels: || (1) Area Two-In-One Disinfectant Spray Country, Reorder #ADI-531, Sold By Area Distributors, Inc., Quincy, IL; || (2) Lawson Fresh Air Disinfectant Spray, Product 90386, Manufactured for Lawson Products, Inc., Corporate Headquarters Des Plaines, IL; || (3) Major Envirocide Country Fresh Disinfectant Spray, Sold By Major Chemical Company, Charlotte, NC; || (4) Concept Potpourri Disinfectant Deodorant, Sold By Manny''s Sanitary Supplies, Inc., New Orleans, LA; || (5) Meyer Century Zip Hospital Disinfectant, A Product of Meyer Laboratory, Inc., Blue Springs, MO; || (6) Pro Chem Deocept Passion Hospital Disinfectant, Sold By Pro-Chem, Inc., Alpharetta, GA; || (7) State Discover Aerosol Disinfectant Country Garden, Stock #109568 and and #109569, Sold By State Industrial Products, Cleveland, OH; || (8) Sterling Quality Nature''s Country Garden Disinfectant Spray, Distributed By Sterling Sanitary Supply Corporation, Woodside, NY; || (9) North Woods TB Plus Spray Disinfectant Spray, Sold By Superior Chemical Corp., Sheboygan, WI; || (10) Renown Potpourri Disinfectant Deodorant, Product REN05056, Distributed by: AmSan, LLC, Deerfield, IL; || (11) Asepsis Asepticide Disinfectant Spray, Handpiece Disinfectant, Country Garden, Distributed By Asepsis International, Inc., Depew, NY; || (12) Dazzle ''D'' Disinfectant Spray Country Garden, Sold By Henry Kraft Inc., Nevada, MO; || (13) TB-Cide Country Garden Hospital Disinfectant, Sold By Industrial Distributors, Inc., Huntington Station, NY; || (14) G-Sep Aromatic Disinfectant Spray, Sold By Moore Research, Inc., St. Louis, MO; || (15) Mt. Hood Chemical Hospit-all New Country Garden Fragrance Disinfectant Spray, Sold By Mt. Hood Chemical Corp., Portland, OR; || (16) IDS Medi-Spray Country Garden Disinfectant Deodorant, Manufactured For Sold By International Distribution System, Inc., Neptune Beach, FL; || (17) Neutron Country Garden Disinfectant Spray, Stock #110030, A product of Nuetron Industries, Phoenix, AZ; || (18) Sunrise Environmental Scientific Disinfectant Spray Country Garden, Sold By Sunrise Environmental Scientific, Sparks, NV; || (19) United Laboratories Flower Power Disinfectant Spray, United 135, Sold By United Laboratories, Inc., St. Charles, IL. || One private label is packaged in a 16-oz. steel aerosol can, Watkins Sanisol Disinfectant Spray, Product 42616, Manufactured for Watkins Incorporated, Winona, MN.

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par ITW Dymon.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    31174
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1408-05
  • Date de mise en oeuvre de l'événement
    2005-02-15
  • Date de publication de l'événement
    2005-08-30
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2008-03-12
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=37308
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    Disinfectant, Medical Devices - Product Code LRJ
  • Cause
    Failed epa required efficacy testing; may not perform as intended.
  • Action
    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

ITW Dymon Medaphene Plus Country Garden Disinfectant Spray, Pseudomonacidal, Virucidal, Mildewcid...
  • Modèle / numéro de série
    Initially recalled lot numbers:  ITW Dymon brand - A66241 and A87241; private labels - A31141, A74241, A75241, A75242, A56241, A66241, and A88241  Expanded recall lot numbers:  ITW Dymon brand - A04141, A04142, A14141, A09141, A91241, A02241, A10341, A82341, A92341, A15341, A15342, and A25341; private label - A81141, B42141, A23141, A23142, A23143, A04141, A84141, A95141, A96141, A96142, A18141, A09141, A80241, A21241, A91241, A42241, A33241, A10341, A90341, C02341, A42341, A42342, A24341, A34341, A34342, A15341, A55341, A70051, A71051, and A12051.
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Distribution was nationwide to wholesalers and own-label distributors.
  • Description du dispositif
    ITW Dymon Medaphene Plus Country Garden 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 #42620. The firm name on the label is ITW Dymon, Olathe, KS. || The product is also distributed under the following private labels: || (1) Area Two-In-One Disinfectant Spray Country, Reorder #ADI-531, Sold By Area Distributors, Inc., Quincy, IL; || (2) Lawson Fresh Air Disinfectant Spray, Product 90386, Manufactured for Lawson Products, Inc., Corporate Headquarters Des Plaines, IL; || (3) Major Envirocide Country Fresh Disinfectant Spray, Sold By Major Chemical Company, Charlotte, NC; || (4) Concept Potpourri Disinfectant Deodorant, Sold By Manny''s Sanitary Supplies, Inc., New Orleans, LA; || (5) Meyer Century Zip Hospital Disinfectant, A Product of Meyer Laboratory, Inc., Blue Springs, MO; || (6) Pro Chem Deocept Passion Hospital Disinfectant, Sold By Pro-Chem, Inc., Alpharetta, GA; || (7) State Discover Aerosol Disinfectant Country Garden, Stock #109568 and and #109569, Sold By State Industrial Products, Cleveland, OH; || (8) Sterling Quality Nature''s Country Garden Disinfectant Spray, Distributed By Sterling Sanitary Supply Corporation, Woodside, NY; || (9) North Woods TB Plus Spray Disinfectant Spray, Sold By Superior Chemical Corp., Sheboygan, WI; || (10) Renown Potpourri Disinfectant Deodorant, Product REN05056, Distributed by: AmSan, LLC, Deerfield, IL; || (11) Asepsis Asepticide Disinfectant Spray, Handpiece Disinfectant, Country Garden, Distributed By Asepsis International, Inc., Depew, NY; || (12) Dazzle ''D'' Disinfectant Spray Country Garden, Sold By Henry Kraft Inc., Nevada, MO; || (13) TB-Cide Country Garden Hospital Disinfectant, Sold By Industrial Distributors, Inc., Huntington Station, NY; || (14) G-Sep Aromatic Disinfectant Spray, Sold By Moore Research, Inc., St. Louis, MO; || (15) Mt. Hood Chemical Hospit-all New Country Garden Fragrance Disinfectant Spray, Sold By Mt. Hood Chemical Corp., Portland, OR; || (16) IDS Medi-Spray Country Garden Disinfectant Deodorant, Manufactured For Sold By International Distribution System, Inc., Neptune Beach, FL; || (17) Neutron Country Garden Disinfectant Spray, Stock #110030, A product of Nuetron Industries, Phoenix, AZ; || (18) Sunrise Environmental Scientific Disinfectant Spray Country Garden, Sold By Sunrise Environmental Scientific, Sparks, NV; || (19) United Laboratories Flower Power Disinfectant Spray, United 135, Sold By United Laboratories, Inc., St. Charles, IL. || One private label is packaged in a 16-oz. steel aerosol can, Watkins Sanisol Disinfectant Spray, Product 42616, Manufactured for Watkins Incorporated, Winona, MN.
  • Manufacturer
    ITW Dymon

Manufacturer

ITW Dymon
  • Adresse du fabricant
    ITW Dymon, 805 E Highway 56, Olathe KS 66061-4914
  • Source
    USFDA