Events

Retiro De Equipo (Recall) de Device Recall Microcyn Solution

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
    60387
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0448-2012
  • Fecha de inicio del evento
    2011-11-09
  • Fecha de publicación del evento
    2012-01-11
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-12-07
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=105226
  • 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
    Unapproved drug claims and those not approved under 510k clearance.
  • Acción
    Oculus Innovative Sciences sent an"URGENT MEDICAL DEVICE RECALL" letter dated November 15, 2011 to all affected customers. The letter describes the product, problem, and the actions to be taken by the customers. The letter instructs customers to identify and remove all affected product from inventory. A Business Reply Card was attached to the letter for customers to complete and return via fax to 1-415-462-5181. Call Oculus Innovative Sciences Customer Service at 1-800-759-9305 for questions regarding this recall.

Device

Device Recall Microcyn Solution
  • Modelo / Serial
    Part number: 84798; - 500 mL Lot numbers: OIS00011-01, exp 1/12; OIS00011-02, exp 1/12; 10l0119, exp 8/12; 10J0145, exp 8/12; 10K0158, exp 8/12; 10K0159, exp 8/12; 10K0160, exp 8/12; 11C0130, exp 2/13.  Part number 84781: - 990 mL lot numbers: OIS00012-01, exp 1/12; OIS00012-02, ecp 1/12; 10E0086-01, exp 5/12; 10l0120, exp 8/12; 10J0145, exp 8/12; 11A0042, exp 1/13; 11B0056, exp 2/13; 11B0081-01, exp 2/13; 11B0082-02, exp 2/13; 11E0192, exp 6/13; 11F0197, exp 6/13.
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    Unclassified
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution.
  • Descripción del producto
    Microcyn Solution with Preservatives (Rx), 16.9 fl oz (500 mL) and 33.5 fl oz. (990 mL) || Ingredients: Electrolyzed Water (99.97%) Sodium Chloride (NaCl) (230 mg/L) and preservatives: Sodium Hypochlorite (Na0Cl) (40 mg/L), Hypochlorous acid (H0CL) (30 mg/L) || -Non Foaming || -Does not contain antibiotics || - Does not facilitate resistance || - No known drug/treatment interactions or contraindications || -laboratory proven in solution inactivation of bacteria, viruses, fungi and spores. || Performance testing: Microcyn Solution with Preservatives has been evaluated by the USP <51> antimicrobial Effectiveness Test and in Time-Kill studies. It has demonstrated effectiveness by reducing the microorganisms listed below and passed the USP antimicrobial Effectiveness test for a category 1 product. || Oculus Innovative Sciences' || Petaluma, CA 94954. || Intended to be used by health care professionals in the management in wounds.
  • 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