Events

Retiro De Equipo (Recall) de Device Recall Arizant Bair Hugger Temperature Management Blanket

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 Arizant 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
    31379
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0855-05
  • Fecha de inicio del evento
    2005-03-11
  • Fecha de publicación del evento
    2005-06-01
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2007-01-10
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=37753
  • 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
    System, Thermal Regulating - Product Code DWJ
  • Causa
    Air channel seals on a limited number of bair hugger model 555 pediatric underbody blankets could separate when inflated with air from bair hugger warming unit. this separation would create a bulging area in the blanket's air channels, which could have a potential to shift the patient's position on the blanket.
  • Acción
    Recall notification was mailed to customers beginning 03/11/05. Customers were informed of the issue and asked to check their inventory for the affected lots. Affected lots found are to be quarantined and customers are to contact Arizant for instruction on returning affected product and receiving replacement product. Distributors are instructed to examine their inventory for affected lots, discontinue distribution and quarantine the lots. Distributors are asked to contact Arizant for returning affected product. If affected product was distributed, Distributors are to contact Arizant with names, addresses and telephone numbers of their accounts so Arizant can immediately inform those accounts of the recall.

Device

Device Recall Arizant Bair Hugger Temperature Management Blanket
  • Modelo / Serial
    lot numbers ranging from 9631 up to and including 9657
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    nationwide
  • Descripción del producto
    Bair Hugger Temperature Management Blanket, Model 555 Pediatric Full Access Blanket. Use only with a Bair Hugger temperature managemen unit. Not Sterile. Do not use if primary packaging has been previously opened or is damaged. Arizant Healthcare Inc., 10393 West 70th Street, Eden Prairie, MN 55344 USA.
  • Manufacturer
    Arizant Inc

Manufacturer

Arizant Inc
  • Dirección del fabricante
    Arizant Inc, 10393 W 70th St, Eden Prairie MN 55344
  • Source
    USFDA