Events

Retiro De Equipo (Recall) de Device Recall 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
    76358
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1477-2017
  • Fecha de inicio del evento
    2017-01-06
  • Fecha de publicación del evento
    2017-03-15
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-09-13
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=152962
  • 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 controller cap of the c2 cyroballoon ablation system may crack as it is tightened onto the controller. that could compromise the integrity and result in damage to the controller cap.
  • Acción
    Firm initially notified consignees who would be using the device in an upcoming procedure on January 6, 2017 to alert them of the potential issue and recommended that products with the affected cap not be used unless it can be checked by a C2 rep. Controller caps will be replaced within a few weeks; facilities will receive replacement caps by mail along with a shipping inventory label for return of those currently on hand. Formal recall letters were sent on January 19, 2017. Letters were sent by e-mail with receipt and read confirmation and follow up by phone call.

Device

Device Recall C2 CryoBalloon Ablation System
  • Modelo / Serial
    All lots distributed between June 23, 2016 and December 20, 2016: UPDATE - expanded to include product distributed from February 1 2016 through February 8, 2017. All numbers below have been updated. Lot numbers: Expiry dates 01122016-02 12-Jul-16; 06242016-01 1-Jan-2017; 11282016-03 2-Jun-2017; 01042016-03 14-Jul-16; 06292016-02 6-Jan-2017; 09202016-01 21-Mar-2017; 07062016-01 8-Jan-2017; 09222016-01 23-Mar-2017; 01252016-02 02-Aug-16; 07082016-02 13-Jan 2017; 09232016-01 28-Mar-2017; 01282016-01 01-Aug-16; 07082016-03 14-Jan-2017; 09232016-02 27-Mar-2017; 01292016-01 02-Aug-16; 07152016-01 21-Jan-2017; 09292016-01 4-Apr-2017; 02022016-03 09-Aug-16; 07152016-02 20-Jan-2017; 09302016-03 4-Apr-2017; 02082016-01 09-Aug-16; 07212016-01 25-Jan-2017; 10052016-02 19-Apr-2017; 02092016-02 11-Aug-16; 07252016-01 28-Jan-2017; 10142016-01 18-Apr-2017; 02112016-02 17-Aug-16; 07262016-01 9-Feb-2017; 10192016-01 24-Apr-2017; 02172016-02 25-Aug-16; 07282016-02 2-Feb-2017; 10212016-01 25-Apr-2017; 02222016-01 26-Aug-16; 08022016-01 17-Feb-2017; 10242016-01 26-Apr-2017; 03012016-01 04-Sep-16; 08032016-02 5-Feb-2017; 10262016-02 1-May-2017; 03072016-01 10-Sep-16; 08112016-01 16-Feb-2017; 10282016-02 8-May-2017; 03102016-02 15-Sep-16; 08232016-01 26-Feb-2017; 11022016-01 9-May-2017; 03152016-03 21-Sep-16; 08262016-01 2-Mar-2017; 11042016-01 10-May-2017; 03282016-02 29-Sep-16; 09022016-01 8-Mar-2017; 11092016-01 15-May-2017; 03292016-01 31-Sep-16; 09092016-01 14-Mar-2017; 11142016-02 16-May-2017; 09122016-02; 15-Mar-2017;  11152016-02 18-May-2017; 04012016-01 06-Oct-16; 09192016-01 19-Mar-2017; 11162016-01 21-May-2017; 09192016-02 21-Mar-2017; 11282016-02 30-May-2017; 04062016-01 12-Oct-16; 11302016-02 02-Jun-17; 12052016-01 08-Jun-17; 04112016-04 14-Oct-16; 12052016-03 06-Jun-17; 04142016-01 20-Oct-16; 12072016-01 09-Jun-17; 04202016-02 21-Oct-16; 12092016-01 13-Jun-17; 05022016-02 05-Nov-16; 12132016-01 19-Jun-17; 05092016-01 11-Nov-16; 12152016-02 20-Jun-17; 05162016-02 18-Nov-16; 01042017-01 04-Jul-17; 05232016-01 25-Nov-16; 01052017-03 19-Jul-17; 05272016-01 02-Dec-16; 01052017-04 19-Jul-17; 06022016-02 09-Dec-16; 01092017-01 12-Jul-17; 06102016-01 14-Dec-16; 01102017-01 18-Jul-17; 06152016-01 21-Dec-16; 01132017-01 18-Jul-17; 06172016-01 23-Dec-16; 01132017-03 17-Jul-17; 07282016-02 02-Feb-17.
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US Nationwide and the countries of Germany, Belgium, The Netherlands United Kingdom and China.
  • Descripción del producto
    C2 CryoBalloon Ablation System - Controller Cap. || C2 CryoBalloon Controller; Cryosurgical Unit, Cryogenic Surgical Device || The affected product is the Controller Cap component only, which is provided to || the customer already assembled onto the Controller. || Model number: FG-1012 || Product Usage: || The C2 CryoBalloon Ablation System is intended for use as a cryosurgical tool in the field of general surgery, specifically for endoscopic applications, to include ablation of Barrett s Esophagus with dysplasia. It is a cryosurgical system with a nitrous oxide cooled balloon that is compatible with a commercially available endoscope with a minimum working channel inner diameter (ID) of 3.7 mm and length of 100 cm. The C2 CryoBalloon System is a system comprised of a Catheter (sterile), Controller (non-sterile), and Cartridge (non-sterile). The Device is used to ablate unwanted tissue by application of extreme cold. The balloon at the distal end of the Catheter comes in contact with tissue and is inflated with nitrous oxide. Tissue is visualized through the inflated balloon, and the treatment site is selected by adjusting the endoscope and Controller position. The nitrous oxide spray cools the balloon to ablate the unwanted tissue, and the nitrous oxide exhausts through the Controller.
  • 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