Events

Retiro De Equipo (Recall) de Device Recall Concept Lemon Scented Disinfectant Deodorant

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-1407-05
  • 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=37307
  • 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
  • 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

Device Recall Concept Lemon Scented Disinfectant Deodorant
  • Modelo / Serial
    Initially recalled lot number: Private label - A66241;  Expanded recalled lot numbers: Private label - A23141 and A28141
  • Distribución
    Distribution was nationwide to wholesalers and own-label distributors.
  • Descripción del producto
    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
    ITW Dymon

Manufacturer

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