Events

Retiro De Equipo (Recall) de Device Recall Codman Cetras

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 Codman & Shurtleff, 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
    68837
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2186-2014
  • Fecha de inicio del evento
    2014-07-03
  • Fecha de publicación del evento
    2014-08-12
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-01-30
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=128827
  • 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
    Shunt, central nervous system and components - Product Code JXG
  • Causa
    To clarify the codman certas valve virtual off (setting 8) pressure specification outlined in the product's instructions for use (ifu).
  • Acción
    Codman Neuro sent an Urgent Medical Device Safety Notification dated July 17, 2014, to clinicians who use the device. The notification clarifies the CODMAN CERTAS Valve virtual off (setting 8) pressure specification outlined in the product's Instructions for Use (IFU). Consignees are also asked to complete the enclosed Acknowledgement Form and fax the completed form to 1-888-239-1305. For questions or concerns regarding this notification, consignees are instructed to contact their local Codman Neuro Representative or Scientific and Medical Affairs at SciMedAffairs@its.jnj.com or (866) 685-7325. For questions regarding this recall call 508-828-2726.

Device

Device Recall Codman Cetras
  • Modelo / Serial
    Lot Numbers: CMBCB2, CMCBLH, CMDBHF, CMGBL5, CMJCMC, CMLBLY, CMNBZK, CNDCV1, CNHC8N, CNI
  • Clasificación del producto
    Neurological Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Worldwide Distribution - USA including AL, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, ND, NE, NJ, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, VT, WA, WI, WV, WY; and Internationally to: Canada, Australia, Austria, Belgium, Brazil, Czech Republic, Denmark, Egypt, Finland, France, Germany, Great Britain, Greece, Hungary, Ireland, Israel, Italy, Kuwait, Lebanon, Luxembourg, Netherlands, Norway, Portugal, Russia, Saudi Arabia, Slovak Republic, Slovenia, South Africa, Spain, Sweden, Switzerland, Turkey.
  • Descripción del producto
    Codman Certas - In Line Valve with Unitized Catheter and Accessories; Product Code: 82-8802 || The Codman Certas Programmable valve is an implantable device that provides constant intraventricular pressure and drainage of CSF (cerebrospinal fluid) for the management of hydrocephalus.
  • Manufacturer
    Codman & Shurtleff, Inc.

Manufacturer

Codman & Shurtleff, Inc.
  • Dirección del fabricante
    Codman & Shurtleff, Inc., 325 Paramount Drive, Raynham MA 02767
  • Empresa matriz del fabricante (2017)
    Johnson & Johnson
  • Source
    USFDA