Events

Retiro De Equipo (Recall) de Device Recall Catheter, C2 CryoBalloon Ablation System

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 C2 Therapeutics, 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
    80180
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2256-2018
  • Fecha de inicio del evento
    2018-03-30
  • Fecha de publicación del evento
    2018-06-05
  • 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=164786
  • 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
    Unit, cryosurgical, accessories - Product Code GEH
  • Causa
    The catheter alignment arrow printed onto the strain relief is not aligned with the detachment feature of the catheter connector, resulting in the potential for the catheter to be attached to the controller in the detach orientation. in this orientation, the catheter is not securely attached to the controller and may be partially (~1cm) ejected from controller.
  • Acción
    On 3/30/2018, C2 Therapeutics issued URGENT FIELD CORRECTION notices to customers via certified mail, return receipt requested. Customers are advised to take the following Action: - Forward a copy of the notice and the enclosures to the department in which is referenced in the notice. - Inspect stock and quarantine products identified within the notice. - The end user of the affected products should complete and return the response form via email to RMA@c2therapeutics.com. The response form contains an RMA number to allow for the return of devices affected by this field action, and enclosed in the package is a Federal Express shipping label for the returned merchandise. Customers with questions can call 650-318-5899, Monday through Friday 8:30 AM - 5 PM, PST.

Device

Device Recall Catheter, C2 CryoBalloon Ablation System
  • Modelo / Serial
    Lot Codes: 02132018-01 & 02162018-03
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Distribution US nationwide.
  • Descripción del producto
    C2 CryoBalloon Focal Catheter, REF FG-1009. C2 CryoBalloon Ablation System is used as a cryosurgical tool in the field of general surgery, specifically for endoscopic applications.
  • Manufacturer
    C2 Therapeutics, Inc.

Manufacturer

C2 Therapeutics, Inc.
  • Dirección del fabricante
    C2 Therapeutics, Inc., 303 Convention Way Ste 1, Redwood City CA 94063-1415
  • Empresa matriz del fabricante (2017)
    HOYA Corp.
  • Source
    USFDA