Events

Retiro De Equipo (Recall) de Transfer/Gait Belt

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 Medline Industries 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
    78363
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0163-2018
  • Fecha de inicio del evento
    2017-08-10
  • 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=159345
  • 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
    Aid, transfer - Product Code IKX
  • Causa
    The locking mechanism on the belt may fail to secure/hold the strap when in locked position potentially allowing the belt strap to slip through the buckle.
  • Acción
    Medline Industries sent an Immediate Action Required Recall Notification letter via First Class mail dated August 10, 2017. The recall was later expanded and customers were notified via letter of the additional lots dated August 21, 2017. Instructions in both letters included to check inventory and quarantine any affected product, complete and return the included response form, coordinate the return of all affected product, and notify customers if the product was further distributed. Additional customers were identified and notified of the recall via the same process on September 19th, 2017. For further questions, please call (866) 359-1704.

Device

Transfer/Gait Belt
  • Modelo / Serial
    Model No. MDT821203WP, all lot numbers that begin with 90317XXXXXX. "X" represents any number.
  • Clasificación del producto
    Physical Medicine Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    USA (nationwide) Distribution to the states of : AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MT, NC, NE, NH, NV, NY, OH , OK, OR, PA, RI, SC, TN, TX, VA, VT, WA, WI and WV.
  • Descripción del producto
    Transfer/Gait Belt, Plastic, Wipeable, packaged in plastic bag, 36 plastic bags per box.
  • Manufacturer
    Medline Industries Inc

Manufacturer

Medline Industries Inc
  • Dirección del fabricante
    Medline Industries Inc, Three Lakes Drive, Northfield IL 60093
  • Empresa matriz del fabricante (2017)
    Medline Industries Inc.
  • Source
    USFDA