Events

Retiro De Equipo (Recall) de Graft Jacket Xpress Flowable Soft Tissue Scaffold OPTIVA IV catheter component

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 LifeCell Corporation.

¿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
    56826
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0162-2011
  • Fecha de inicio del evento
    2010-09-13
  • Fecha de publicación del evento
    2010-10-28
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-08-17
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=94590
  • 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
    Accessories, catheter - Product Code KGZ
  • Causa
    Graft jacket xpress kits contain catheters that will expire or have already expired prior to the labeled expiration of the human tissue component of the product on the outer box.
  • Acción
    Lifecell Corporation, Branchburg, NJ initiated a recall to their distributor Wright Medical Technology, Arlington, TN on 9/13/2010.

Device

Graft Jacket Xpress Flowable Soft Tissue Scaffold OPTIVA IV catheter component
  • Modelo / Serial
    B27815A, Item no 663002, Graft Jacket Xpress 2011-01, Optiva IV Catheter Expiration 2010-05 B28417A, Item no 663002, Graft Jacket Xpress 2010-10, Optiva IV Catheter Expiration 2010-05 B28419A, Item no 663002, Graft Jacket Xpress 2010-10, Optiva IV Catheter Expiration 2010-05 B28420A, Item no 663002, Graft Jacket Xpress 2010-10, Optiva IV Catheter Expiration 2010-05 B29170A, Item no 663002, Graft Jacket Xpress 2010-12, Optiva IV Catheter Expiration 2010-05 B29172A, Item no 663002, Graft Jacket Xpress 2010-12, Optiva IV Catheter Expiration 2010-05 B29174A, Item no 663002, Graft Jacket Xpress 2010-12, Optiva IV Catheter Expiration 2010-05 B29381A, Item no 663002, Graft Jacket Xpress 2011-04, Optiva IV Catheter Expiration 2010-05 B29923A, Item no 663002, Graft Jacket Xpress 2011-03, Optiva IV Catheter Expiration 2010-05 B29927A, Item no 663002, Graft Jacket Xpress 2011-02, Optiva IV Catheter Expiration 2010-05 B30035A, Item no 663002, Graft Jacket Xpress 2011-06, Optiva IV Catheter Expiration 2010-05 B30036A, Item no 663002, Graft Jacket Xpress 2011-02, Optiva IV Catheter Expiration 2010-05 B30039A, Item no 663002, Graft Jacket Xpress 2011-02, Optiva IV Catheter Expiration 2010-05 B3004A, Item no 663002, Graft Jacket Xpress 2011-02, Optiva IV Catheter Expiration 2010-05 B30043A, Item no 663002, Graft Jacket Xpress 2011-02, Optiva IV Catheter Expiration 2010-05 B30701A, Item no 663002, Graft Jacket Xpress 2011-04, Optiva IV Catheter Expiration 2010-05 B30702A, Item no 663002, Graft Jacket Xpress 2011-04, Optiva IV Catheter Expiration 2010-05 B30703A, Item no 663002, Graft Jacket Xpress 2011-04, Optiva IV Catheter Expiration 2010-05 B30708A, Item no 663002, Graft Jacket Xpress 2011-04, Optiva IV Catheter Expiration 2010-05 B31035A, Item no 663002, Graft Jacket Xpress 2011-04, Optiva IV Catheter Expiration 2010-05 B31036A, Item no 663002, Graft Jacket Xpress 2011-05, Optiva IV Catheter Expiration 2010-05 B31038A, Item no 663002, Graft Jacket Xpress 2011-04, Optiva IV Catheter Expiration 2010-05 B32670A, Item no 663002, Graft Jacket Xpress 2011-08, Optiva IV Catheter Expiration 2010-05 B32674A, Item no 663002, Graft Jacket Xpress 2011-08, Optiva IV Catheter Expiration 2010-05 B34512A, Item no 663002, Graft Jacket Xpress 2011-12, Optiva IV Catheter Expiration 2010-05 B34514A, Item no 663002, Graft Jacket Xpress 2011-12, Optiva IV Catheter Expiration 2010-06 B34516A, Item no 663002, Graft Jacket Xpress 2011-12, Optiva IV Catheter Expiration 2010-05 B35329A, Item no 663002, Graft Jacket Xpress 2012-02, Optiva IV Catheter Expiration 2011-06 B35334A, Item no 663002, Graft Jacket Xpress 2012-02, Optiva IV Catheter Expiration 2011-06 B35336A, Item no 663002, Graft Jacket Xpress 2012-02, Optiva IV Catheter Expiration 2011-06 B35623A, Item no 663002, Graft Jacket Xpress 2012-02, Optiva IV Catheter Expiration 2011-06 B35624A, Item no 663002, Graft Jacket Xpress 2012-03, Optiva IV Catheter Expiration 2011-06 B35625A, Item no 663002, Graft Jacket Xpress 2012-03, Optiva IV Catheter Expiration 2011-06 B35627A, Item no 663002, Graft Jacket Xpress 2012-03, Optiva IV Catheter Expiration 2011-06 B37232A, Item no 663002, Graft Jacket Xpress 2012-06, Optiva IV Catheter Expiration 2011-06 B38274A, Item no 663002, Graft Jacket Xpress 2012-06, Optiva IV Catheter Expiration 2011-06 B5835A, Item no 663002, Graft Jacket Xpress 2010-10, Optiva IV Catheter Expiration 2010-05 B6092A, Item no 663002, Graft Jacket Xpress 2010-12, Optiva IV Catheter Expiration 2010-05 C26276A, Item no 663002, Graft Jacket Xpress 2011-09, Optiva IV Catheter Expiration 2010-05 C6056A, Item no 663002, Graft Jacket Xpress 2010-10, Optiva IV Catheter Expiration 2010-05 C6072A, Item no 663002, Graft Jacket Xpress 2010-10, Optiva IV Catheter Expiration 2010-05 C6085A, Item no 663002, Graft Jacket Xpress 2010-12, Optiva IV Catheter Expiration 2010-05
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution: USA, to distributor in TN
  • Descripción del producto
    IV Catheter - Optiva IV Catheter. This is found in box labeled 'Graft Jacket Xpress Flowable Soft Tissue Scaffold'; labeled by Wright.
  • Manufacturer
    LifeCell Corporation

Manufacturer

LifeCell Corporation
  • Dirección del fabricante
    LifeCell Corporation, 1 Millennium Way, Somerville NJ 08876-3876
  • Empresa matriz del fabricante (2017)
    Allergan Public Limited Company
  • Source
    USFDA