Events

Retiro De Equipo (Recall) de PROLENE

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 McKesson General Medical 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
    27682
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0249-04
  • Fecha de inicio del evento
    2003-10-31
  • Fecha de publicación del evento
    2004-07-20
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-08-04
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=30331
  • 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
    Mesh, Surgical, Polymeric - Product Code FTL
  • Causa
    Counterfeit product is an unapproved medical device with associated potential health hazard.
  • Acción
    The distributor notified all distribution centers and field personnel by e-mail on 10/29/03. The firm''s centers were instructed to inspect and quarantine lots RBE609 and RJJ130. Field personnel were instructed to notify customers to quarantine counterfeit product and any suspect product. On 10/30/03, the recalling distributor notified its field representatives to inspect and quarantine all lots of the mesh. The firm issued a recall notification with reply form to all consignees receiving surgical mesh product since Jan 03.

Device

PROLENE
  • Modelo / Serial
    All codes, including the lots that the manufacturer of authentic product specified as counterfeit, RBE609 EXP1/07 and RJJ130 EXP 7/07.
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Counterfeit and authentic product had been shipped to 221 hospitals and surgery centers in the continental US.
  • Descripción del producto
    PROLENE* Mesh, Polypropylene Non Absorbable Synthetic Surgical Mesh, PMII, 3'x6', each mesh in a sealed pouch package, 6 packages per papercard carton
  • Manufacturer
    McKesson General Medical Corporation

Manufacturer

McKesson General Medical Corporation
  • Dirección del fabricante
    McKesson General Medical Corporation, 5601 Eastport Boulevard, Richmond VA 23231
  • Source
    USFDA