Events

Retiro De Equipo (Recall) de Device Recall Presource PBDS, Total Hip, Kit, Circulator

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 Cardinal Health, Medical Products & Services.

¿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
    64736
  • Clase de Riesgo del Evento
    Class 1
  • Número del evento
    Z-1202-2013
  • Fecha de inicio del evento
    2013-03-26
  • Fecha de publicación del evento
    2013-05-03
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-04-12
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=116920
  • 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
    Anesthesia breathing circuit kit - Product Code OFP
  • Causa
    Various presource kits contain a pre-assembled filter and anesthesia circuit that may contain outer plastic packaging on one or more components. if the packaging is removed without disassembling the components, remnants of the plastic from the packaging material may become lodged in the filter potentially causing an obstruction of airflow.
  • Acción
    Affected consignees were notified with a letter, dated March 26, 2013, sent via FedEx Priority, of this action. Cardinal Sales Representatives will also be advised and will verbally communicate the action to affected customers. The letter identified the affected product and the problem. Customers are to locate any affected product and quarantine them. In addition, clinicians should be informed of the issue; and, warning labels should be affixed to the front of each kit instructing users to remove and discard the Anesthesia Circuit and Filter Assembly. In order to confirm receipt of this action and completion of labeling the product, the enclosed Acknowledgement Form should be completed and returned to the number provided. If customers do now wish to accept overlabeled product or to overlabel the product in their possession, they are to contact Presource Sales Operations at 800-766-0706, or their sales representative for further instruction. Customers are to contact Cardinal Health Quality Systems at 800-292-9332, if they have any questions or need special assistance.

Device

Device Recall Presource PBDS, Total Hip, Kit, Circulator

Manufacturer

Cardinal Health, Medical Products & Services
  • Dirección del fabricante
    Cardinal Health, Medical Products & Services, 1430 Waukegan Road, Attn V. Mueller Qa, Park City IL 60085
  • Empresa matriz del fabricante (2017)
    Cardinal Health
  • Source
    USFDA