Events

Retiro De Equipo (Recall) de 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.

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por ITW Dymon.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    31174
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1406-05
  • Fecha de inicio del evento
    2005-02-15
  • Fecha de publicación del evento
    2005-08-30
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2008-03-12
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=37306
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    Disinfectant, Medical Devices - Product Code LRJ
  • Causa
    Failed epa required efficacy testing; may not perform as intended.
  • Acción
    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 Orange Disinfectant Spray, Pseudomonacidal, Virucidal, Mildewcidal, Fung...
  • Modelo / Serial
    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.
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Distribution was nationwide to wholesalers and own-label distributors.
  • Descripción del producto
    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
    ITW Dymon

Manufacturer

ITW Dymon
  • Dirección del fabricante
    ITW Dymon, 805 E Highway 56, Olathe KS 66061-4914
  • Source
    USFDA