Events

Retiro De Equipo (Recall) de Device Recall Puracyn OTC Wound & Skin Care 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-0449-2012
  • 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=105228
  • 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 Puracyn OTC Wound & Skin Care Solution
  • Modelo / Serial
    Part number: 6000;80003 (8 oz trigger spray): Lot numbers: 10E0084-01, exp 11/11; 10F0099, exp 12/11; 10F0105, exp 12/11; 041311-01, exp 5/12.  Part number: 6002; 80001, (8 oz finger pump); lot number s: 041311-01, exp 5/12;  081710-01, exp.9/11;  120810-01, exp 2/2012; 073010-02, exp 11/11.  Part number: 6004; 80005. 16 oz with insert:  061511-02. exp 12/12.
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    Unclassified
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution.
  • Descripción del producto
    Puracyn OTC; || Wound & Skin Care Solution with Preservatives; Sold in 8 fl oz (trigger spray and finder pump) and 16 fl oz pump with insert. || Kills 99.99% of Staph, MRSA, Strep and other Infectious Germs in 30 seconds in solution. || Does not contain Antibiotics, Steroids or Alcohol. || -Cleans infected wounds in one step || - Safe to use around eyes, nose, m mouth and open wounds || - Accelerated healing of minor wounds by keeping the wound clean || -Non-toxic and non-irritating. || Manufactured by Oculus Innovative Sciences for Innovaycen, Inc. || 3546 N. Riverside Ave. Rialto, CA 92377 || Made in USA. || Intended for OTC use for the management of skin abrasions, lacerations, minor irritations, cuts, and intact skin.
  • 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