Events

Retiro De Equipo (Recall) de Nanosil Spray Gel

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 Conseal International, 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
    79962
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1627-2018
  • Fecha de inicio del evento
    2018-04-25
  • Estado del evento
    Open, Classified
  • País del evento
    United States
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=164041
  • 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
    A recent fda inspection of the firm revealed significant current good manufacturing practices (cgmp) deficiencies including lack of data to support products conform to final specifications, and lack of expiration dates on the product being recalled.
  • Acción
    ConSeal sent an Urgent Medical Device Recall letter dated April 25, 2018, to its customers via email. The letter instructed customers to locate the affected product, quarantine, and return it to the firm. Customers were also instructed to complete and return the customer response form, and inform any users the customer distributed the product to. Customers may contact the firm by calling 782-352-0490. For further questions, please call (781) 278-0010.

Device

Nanosil Spray Gel
  • Modelo / Serial
    Product does not bear lot codes. All product lacking lot codes and expiration dates is being recalled.
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    Unclassified
  • ¿Implante?
    No
  • Distribución
    US Distribution to the states of : AL, MS, and MA.
  • Descripción del producto
    Nanosil Spray Gel, "***IMMUNE SYSTEM SUPPORT***ENGINEERED NANO-SILVER SOLUTION***", Net. Wt. 4 fl. oz./118mL, Catalog No. NSP-04 || The product is a topical spray used to treat discomfort and other pathological conditions affecting exposed soft tissues of the body caused by microbial infections.
  • Manufacturer
    Conseal International, Inc.

Manufacturer

Conseal International, Inc.
  • Dirección del fabricante
    Conseal International, Inc., 90 Kerry Place, Suite 2, Norwood MA 02062-4765
  • Empresa matriz del fabricante (2017)
    Conseal International, Inc.
  • Source
    USFDA