Retiro De Equipo (Recall) de Adhesive Remover Wipe

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 Smith & Nephew Inc..

¿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
  • ID del evento
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
  • Fecha de inicio del evento
  • Fecha de publicación del evento
  • Estado del evento
  • País del evento
  • Fecha de finalización del evento
  • Fuente del evento
  • URL de la fuente del evento
  • 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
    Solvent, adhesive tape - Product Code KOX
  • Causa
    Smith & nephew, inc., st. petersburg, fl is recalling multiple lot numbers of the following products: remove universal adhesive remover wipes, uni-solve adhesive remover wipes, skin-prep protective wipes, peri-prep protective wipes, and no-sting skin-prep protective wipes. these products were manufactured by h&p; industries dba the triad group who has initiated a recall of products manufactured i.
  • Acción
    Smith & Nephew Inc. sent an "URGENT DEVICE CORRECTION" letter dated April 8, 2011 to all customers who received the recalled products. The letter described the product, problem and the appropriate actions to be taken. Customers are instructed to immediately discontinue using the recalled products, examine their inventory, and follow the return or disposition instructions provided. The letter instructed customers to seek an alternative product for use. Distributors are instructed to provide the same instructions to their customers supplied with the recalled products. If you have any questions contact the Recall Hotline Center at 1-888-613-0271.


  • Modelo / Serial
    UNISOLVE 402300 Lot #  0F195,  0F197,  0F198,  0F223,  0F224,  0F228,  0F229,  0F239,  0H185,  0H226,  0H228,  0H229,  0K207,  0K208,  0K209,  0K233,  0K234,  0M136,  0M137,  0M151,  0M238,  1A103,  1B129,  1B130,  1B131,  1B132.   REMOVE CE 59403125:  0E219,  0E226,  0F242,  0G116,  0H256,  0J233,  0J262,  0J263,  0M178,  0M179,  1A106,  1A181,  1A182,  1A192.
  • Clasificación del producto
  • Clase de dispositivo
  • ¿Implante?
  • Distribución
    Worldwide Distribution -- USA (nationwide) including the states of: NC, PA, NM, OR, VA, TN, NY, OR, AL, IL, MN, TX, and Puerto Rico and the countries of: Australia, Canada, England, France, Germany, Hong Kong, Japan, Mexico, New Zealand, Singapore, South Africa, Taiwan, and United Kingdom
  • Descripción del producto
    Brand: UNI-SOLVE Adhesive Remover Wipe  Pouch, 50 Count Box Label || ***smith&nephew;***#402300*** UNI-SOLVE Adhesive Remover Wipe Effectively removes tapes and adhesives Reduces irritation and risk of skin stripping Easy to use, no mess Gentle***1 wipe*** For external use only. Avoid eyes - Use with adequate ventilation. Keep out of reach of children. INGREDIENTS: C10-11 Isoparaffin, Isopropyl Alcohol, Dipropylene Glycol Methyl Ether, Aloe Extract, Fragrance. || Brand UNI-SOLVE Adhesive Remover Wipes - Carton Label: || smith&nephew; Adhesive Remover Wipes ***UNI-SOLVE***Quantity 20 Cartons of 50 Code #402300*** || -------------------- || Brand: REMOVE CE Adhesive Remover Wipe - Pouch Label and 50 Count Box Label: || ***smith&Nephew;***#59403125***REMOVE***US Patent no. 5336207***CE***. || Formulation F-57 S&N; Product Code 402300 UNI-SOLVE Adhesive Remover Wipes. || Formulation F-57 S&N; Product Code 59403125 REMOVE CE Adhesive Remover. || Product Usage: Reduce adhesive trauma to the skin by thoroughly dissolving dressing tape and appliance adhesives. || .
  • Manufacturer


  • Dirección del fabricante
    Smith & Nephew Inc., 970 Lake Carillon Dr, Ste 110, Saint Petersburg FL 33716-1130
  • Empresa matriz del fabricante (2017)
  • Source