Events

Retiro De Equipo (Recall) de SEEKER(R) Crossing Support Catheter

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 Peripheral Vascular 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
    79896
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1802-2018
  • Fecha de inicio del evento
    2018-04-16
  • Fecha de publicación del evento
    2018-05-11
  • 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=163824
  • 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
    Catheter, percutaneous - Product Code DQY
  • Causa
    Device is at risk of having detectable levels of bacterial endotoxin present on the packaging hoop that the catheter is packaged in. the bacterial endotoxin levels for the catheters are within acceptable levels; however, if bacterial endotoxins are present on the packaging hoops it may have the potential for cross-contamination in a clinical setting.
  • Acción
    The firm initiated the recall via an Urgent Medical Device Recall Notification letter on 04/16/2018. The letter identified the affected device, reason for the recall, and required actions. Customers are asked to check their inventory for and remove the affected product code and lot number combinations. The Recall and Effectiveness Check Form should be completed and returned even if affected product has been used. The firm requested the return of the recalled product; and will provide a replacement after all information has been verified and product returned. The completed form can be emailed to BPV.CustomerSupportCenter@crbard.com or faxed to 1-800-994-6772.

Device

SEEKER(R) Crossing Support Catheter
  • Modelo / Serial
    UDI: (01)00801741067921(17)191115(10)VTBY0563, Lot Number: VTBY0563
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution
  • Descripción del producto
    BARD PERIPHERAL VASCULAR SEEKER(R) Crossing Support Catheter, 0.035", 150 cm, REF SK15035M. || Intended to support a guidewire during access into the vasculature.
  • Manufacturer
    Bard Peripheral Vascular Inc

Manufacturer

Bard Peripheral Vascular Inc
  • Dirección del fabricante
    Bard Peripheral Vascular Inc, 1625 W 3rd St Bldg 1, Tempe AZ 85281-2438
  • Empresa matriz del fabricante (2017)
    Becton, Dickinson and Company
  • Source
    USFDA