Events

Retiro De Equipo (Recall) de Device Recall SafeCut Safety Scalpels

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 Bard Access Systems.

¿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
    70822
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1443-2015
  • Fecha de inicio del evento
    2014-06-24
  • Fecha de publicación del evento
    2015-04-14
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-11-05
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=134910
  • 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
    Handle, scalpel - Product Code GDZ
  • Causa
    Potential for inadvertent scalpel stick injury involving the safety scalpel.
  • Acción
    Bard sent an Urgent Notification letter date June 26, 2014 to affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed on the proper device use and safety mechanism activation of the Safe-Cut Safety Scalpel. For questions call coordinator, Shelly Gilbert, at 1-800-290-1689.

Device

Device Recall SafeCut Safety Scalpels
  • Modelo / Serial
    Lot numbers: 1174108,1174108,1174108D,1174108D,1174108D,1174108D,1174108D,1174108D,1175108,1175108,1175108,1175108,1175108,1194108,1194108,1194108,1194108D,1194108D,1194108D,1194108D,1194108D,1194118,1194118,1194118,1194118,1194118,1275108,1275108,1275108,1275108,1275108D,1275108D,1275108D,1275108D,1275108D,1295108,1295108D,1295108D,1295108D,1295108D,1295108D,1295108D,1295108D,1295108D,1295108D,1295108FD,1295108FD,1295118,1295118,1295118,1295118,1295118,1385108Q,1385108QD,1385108QD,1385108QD,1385108QD,1386108,1386108D,1386108D,1395108QD,1395108QD,1396118,2194108,2194108,2295108,3154108,3154108,3174108,3174108,3174108,3174108,3174108d,3175108,3194108,3194108D,3255108,3255108,3255108,3255108,3274108,3275108,3275108d,3275108d,3295108,3295108,3295108,3295108d,3295108FD,3295108FD,3385108Q,3385108QD,3385108QD,3385108QD,3386108,3386108,3386108,3386108d,3395108Q,3395108QD,3395108QD,3396108,3396118,4154108,4154108,4154108,4154108D,4154108D,4154108D,4154108D,4154108D,4154108D,5575240,5605150,5605150,5605150,5605200,5605200,5605200,5605200,5605240,5605240,5605300,5605300,5615150,5615150,5615150,5615150,5615150,5615200,5615200,5615200,5625150,5625150,5625240,5655200,5755200,5766150,5766150,6174108,6194108,6194108,6194118,6194118,6295108,6295108,9173108,9173108D,9174108,9174108,9194108,9194108,9194108,9194108D,9275108d,9275108d,9275108f,9275108f,9275108f,9295108fd,9295108fd,9385108Q,9385108Q,9385108QD,9385108QD,9385108QD,9395108QD,9395108QD,9395108QD,9395118Q,9717308,
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US Nationwide
  • Descripción del producto
    Bard Peripherally Inserted Central Catheter (PICC) and Dialysis catheter kits containing Safe-Cut Safety Scalpels.
  • Manufacturer
    Bard Access Systems

Manufacturer

Bard Access Systems
  • Dirección del fabricante
    Bard Access Systems, 605 North 5600 West, Salt Lake City UT 84116-3738
  • Empresa matriz del fabricante (2017)
    Becton, Dickinson and Company
  • Source
    USFDA