Events

Retiro De Equipo (Recall) de Device Recall Codman

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
    57340
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2029-2011
  • Fecha de inicio del evento
    2010-11-30
  • Fecha de publicación del evento
    2011-04-20
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-03-14
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=97580
  • 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
    device, monitoring, intracranial pressure - Product Code GWM
  • Causa
    Packaging defect may compromise sterility of device.
  • Acción
    The firm, Codman, sent an "Important Notice Urgent- Voluntary Product Recall Notification" letter dated November 30, 2010 to its customers via FedX. On January 7, 2011, Codman expanded the recall to four additional product codes.On January 31, 2011, the firm issued a supplemental recall letter and identified one additional product code: 80-11197. The letters described the product, problem and actions to be taken. The customers were instructed to identify the unused affected products in their inventory and follow the recall instructions provided: 1) If you have NO product to return, please advise Codman as soon as possible using the FACSIMILE form attached and fax to 508-828-6118 and 2) if you DO have product to return, please call 1-800-225-0460, Option 4, for instructions for return. Codman is presently working toward supplying replacement products as soon as possible. Please call Customer Service to check on the status of product availability at 1-800-225-0460. Should you have any questions regarding this recall, please call Customer Service at 1-800-225-0460 or your local Codman Representative.

Device

Device Recall Codman
  • Modelo / Serial
    Lot Codes:  421302 424870 424871 SW10-3731 430880 427693 429015 430532 434231 MA216  BB235  BB317  DB214  EB338  GB263  JB240  KB216  MB219
  • Clasificación del producto
    Neurological Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution: USA including states of :AL, FL,GA, KY, MA, MI, MN, MS, OR, PA, RI, UT,WI and WV; and countries including: Argentina, Australia, Canada, Bahamas , Belgium, Dubai, Japan, Madrid, Mexico, New Zealand, Saudia Arabia, UAE, Uruguay, and United Kingdom.
  • Descripción del producto
    Ghajar Guide Ventriculostomy Kit || Product Code: 80-1185 || This is a single use, disposable drill kit designed for gaining access to the cranium for therapeutic and/or diagnostic procedures
  • 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