Events

Retiro De Equipo (Recall) de Device Recall Vistec TM XRay Detectable Sponges

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 Covidien LP.

¿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
    78968
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0534-2018
  • Fecha de inicio del evento
    2017-07-17
  • 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=160979
  • 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
    Gauze/sponge, internal, x-ray detectable - Product Code GDY
  • Causa
    Medtronic is voluntarily recalling two production lots of its covidien vistec" x-ray detectable sponges de to possible contamination with human blood caused by handling of the product during the manufacturing process and prior to final packaging and ethylene oxide sterilization.
  • Acción
    Medtronic sent an Urgent Medical Device Recall letter dated July 17, 2017 to their customers via Federal Express or certified mail. The letter identified the affected product, problem and actions to be taken. Customers are requested to quarantine, discontinue use and return affected product. Customers were instructed to acknowledge receipt of the Urgent Field Corrective Action Notice. For questions contact your Medtronic representative or Customer Service at 800-962-9888, option 2.

Device

Device Recall Vistec TM XRay Detectable Sponges
  • Modelo / Serial
    Lot Numbers: 17E121362, 17E121262 UDI: 10884527016990; 20884527016997
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    U.S., Gov Accts, and foreign countries: PA, PR, CO.
  • Descripción del producto
    Covidien Vistec" X-Ray Detectable Sponges, 7317 Vistec" X-Ray Detectable Sponges Sponge. || product Usage: || Vistec X-Ray Detectable Sponges are medical absorbent devices intended to be used internally within the body cavity to control bleeding or for applying medication. These sponges contain unique dual-colored elements that combines blue radiopaque strand with white strand, which is visible when sponge is saturated with blood.
  • Manufacturer
    Covidien LP

Manufacturer

Covidien LP
  • Dirección del fabricante
    Covidien LP, 1430 Marvin Griffin Rd, Augusta GA 30906-3851
  • Empresa matriz del fabricante (2017)
    Medtronic plc
  • Comentario del fabricante
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    USFDA