Events

Retiro De Equipo (Recall) de Device Recall SPAG2 unit nebulizers

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 Valeant Pharmacueticals International.

¿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
    77289
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0384-2018
  • Fecha de inicio del evento
    2017-03-13
  • 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=155627
  • 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
    Nebulizer (direct patient interface) - Product Code CAF
  • Causa
    Spag-2 unit nebulizers from lot j0571670ra were tested at next breath for particle sizing under the validated method, nb-tm-261, in november 2016. the particle size specification set in nb-spec-039 for dv10, dv50, & dv90 are a mean value of no more than 3.0¿m, 5.5 ¿m, and 15¿m respectively. initial testing of the nebulizers yielded four units that delivered particle sizes that did not meet the specification (nb-spec-039). the out of specification (oos) nebulizers were cleaned per the approved spag-2 procedure, spe-000127228 rev 2, to remove any product residue and were then re-evaluated. secondary testing yielded that three of the four nebulizers still did not meet the particle size specification. it was concluded that the 3 nebulizers from spag-2 lot j0571670ra failed to meet (spe-000127228 rev 2) did not resolve the high droplet size distribution values observed.
  • Acción
    On April 4, 2017 Valeant Pharmaceuticals North America distributed Medical Device Voluntary Product Recall and Acknowledgement Forms to their customers via USPS. Valeant Pharmaceuticals are directly contacting those customers who have been shipped affected SPAG-2 devices to arrange pick up and testing of the nebulizer component. Only half of the nebulizers will be picked-up for particle-size testing at each account to prevent shortages of VIRAZOLE, which can only be used with the SPAG-2 device. Nebulizers that pass testing will be cleaned and returned. Nebulizers that do not pass testing will be disposed, and new nebulizers will be distributed to facilities once they become available. Customers are encouraged to complete and return the Acknowledgement Form via email to: valeant3012@stericycle.com.

Device

Device Recall SPAG2 unit nebulizers
  • Modelo / Serial
    Lot Number J0571670RA*/Serial Number 337170600007; Lot Number J0571670R*/Serial Number 337170600007; Lot Number J0571670/Serial Number 337170600007; Lot Number L0197340/Serial Number 340150600003; Lot Number K1900650/Serial Number 340150600003.
  • Clasificación del producto
    Anesthesiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    US Nationwide & Canada
  • Descripción del producto
    Small Particle Aerosol Generator Model SPAG-2 6000 Series (SPAG-2). The SPAG-2 medical device is a pneumatic flow system indicated for the administration of Virazole (ribavirin) aerosol. Driven by a pressurized gas (air or blended oxygen) and uses a nebulizer to generate a fine aerosol of hydrated Virazole. || --- CDRH Classification Name: Nebulizer (Direct Patient Interface)
  • Manufacturer
    Valeant Pharmacueticals International

Manufacturer

Valeant Pharmacueticals International
  • Dirección del fabricante
    Valeant Pharmacueticals International, 1400 Goodman St N, Rochester NY 14609-3547
  • Source
    USFDA