Events

Retiro De Equipo (Recall) de Device Recall FROWound cleanser/ Dressing, wound, drug

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 Oculus Innovative Sciences, 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
    Recall
  • ID del evento
    75770
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0763-2017
  • Fecha de inicio del evento
    2016-11-21
  • Fecha de publicación del evento
    2016-12-14
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-06-13
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=151214
  • 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
    Dressing, wound, drug - Product Code FRO
  • Causa
    Firm became aware that professional samples of ceramax are not meeting stability standards set for the product.
  • Acción
    Oculus issued Medical Device Recall letters dated November 21, 2016, to Sales reps notifying them to stop all further distribution and immediately remove the affected lots of Recall product from sample inventory. Customers were also instructed to sign the Response form verifying receipt of the letter. Customers with questions were instructed to call Oculus Innovative Science-Regulatory Affairs at 707-559-7181. For questions regarding this recall call 559-7191.

Device

Device Recall FROWound cleanser/ Dressing, wound, drug
  • Modelo / Serial
    Lot 3045639, expiration date: 01/2018
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    Unclassified
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution
  • Descripción del producto
    Ceramax Skin Barrier Cream: || NET WT 0.1 OZ (3 g professional sample - not for retail sale) || Under the supervision of a health care professional, Ceramax is intended to be used as a topical skin care preparation to relieve and to manage the burning and itching associated with various dermatoses including atopic dermatitis, irritant contact dermatitis, radiation dermatitis, and other dry skin conditions, by maintaining a moist wound and skin environment. || General and Plastic Surgery: Ceramax is intended to be used as a topical skin care preparation to relieve and to manage the burning and itching associated with various dermatoses including atopic dermatitis, irritant contact dermatitis, radiation dermatitis, and other dry skin conditions, by maintaining a moist wound and skin environment.
  • Manufacturer
    Oculus Innovative Sciences, Inc.

Manufacturer

Oculus Innovative Sciences, Inc.
  • Dirección del fabricante
    Oculus Innovative Sciences, Inc., 1129 N McDowell Blvd, Petaluma CA 94954-1110
  • Empresa matriz del fabricante (2017)
    Sonoma Pharmaceuticals Inc.
  • Source
    USFDA