Events

Retiro De Equipo (Recall) de Device Recall Hydrofilm

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 Hartmann USA, 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
    58136
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
    Z-1866-2011
  • Fecha de inicio del evento
    2011-02-11
  • Fecha de publicación del evento
    2011-04-01
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-08-12
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=98447
  • 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
    Dressing, wound and burn, occlusive - Product Code MGP
  • Causa
    Misbranded; the expiry date on the primary packing incorrectly indicates 2010-10, instead of 2015-10. consignees were notified by letter on/about 02/11/2011. they were advised to examine their inventory and not to use any of the affected product and to return it to paul hartmann. a response form was included to be completed and returned to paul hartmann. they were further instructed to pass the no.
  • Acción
    Hartmann USA, Inc. sent letter to the Consignees on 2/11/11. They were advised to examine their inventory and not to use any of the affected product and to return it to Hartmann USA, Inc. A response form was included to be completed and returned to Hartmann USA, Inc. They were further instructed to pass the notice on to their consignees if distributed. For questions, call (803) 325-7600.

Device

Device Recall Hydrofilm
  • Modelo / Serial
    Lot number: 000543118
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    Unclassified
  • ¿Implante?
    No
  • Distribución
    Nationwide -- Including CA, GA, IL, MO, MS, TX, and VA.
  • Descripción del producto
    HydroHydrofilm is for use as a post-operative and primary dressing to protect against secondary infection and to cover non-exudating wounds and for use as a secondary dressing for fixation of catheters or cannulae.film, 10cm x 12.5 cm, Paul Hartmann AG, 89522 Heidenhiem, Germany
  • Manufacturer
    Hartmann USA, Inc

Manufacturer

Hartmann USA, Inc
  • Dirección del fabricante
    Hartmann USA, Inc, 481 Lakeshore Pkwy, Rock Hill SC 29730-4205
  • Empresa matriz del fabricante (2017)
    Schwenk Limes Gmbh & Co. Kg
  • Source
    USFDA