Events

Retiro De Equipo (Recall) de PROLENE* Mesh, Polypropylene Non Absorbable Synthetic Surgical Mesh, PMII, 3''x6'', each mesh in a sealed pouch package, 6 packages per papercard carton. Cartons labeled in part ***ETHICON, INC., a Johnson & Johnson company SOMERVILLE, NEW JERSEY 08876-0151 ***STERILE: Sterility of contents guaranteed unless package has been opened or damaged***

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 Owens & Minor Distribution, 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
    27656
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0251-04
  • Fecha de inicio del evento
    2003-11-03
  • Fecha de publicación del evento
    2003-12-18
  • 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=30285
  • 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 the firm's chain of warehouses by e-mail on 10/31/03 to identify, segregate and quarantine potential counterfeit product. The distributor then notified consignees by letter on 11/3/03. The letter advised that customers may have received 2 lots of counterfeit product and described the features for identity, which were provided by the manufacturer (www.ethicon.com) of the authentic product. The notification further instructed that appropriate healthcare professionals should be advised of the recall. Consignees were instructed to quarantine the specified lots for return.

Device

PROLENE* Mesh, Polypropylene Non Absorbable Synthetic Surgical Mesh, PMII, 3''x6'', each mesh in ...
  • Modelo / Serial
    Lots RBE609 EXP 1/07, RJJ130 EXP7/07
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Counterfeit and authentic product was distributed to warehouses and 205 medical facilities nationwide.
  • 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. Cartons labeled in part ***ETHICON, INC., a Johnson & Johnson company SOMERVILLE, NEW JERSEY 08876-0151 ***STERILE: Sterility of contents guaranteed unless package has been opened or damaged***
  • Manufacturer
    Owens & Minor Distribution, Inc.

Manufacturer

Owens & Minor Distribution, Inc.
  • Dirección del fabricante
    Owens & Minor Distribution, Inc., 4800 Cox Road, Glen Allen VA 23060
  • Source
    USFDA