Events

Retiro De Equipo (Recall) de Device Recall Sterilux

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
    61899
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1858-2012
  • Fecha de inicio del evento
    2012-05-14
  • Fecha de publicación del evento
    2012-06-22
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-10-06
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=109342
  • 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
    Gauze/sponge,nonresorbable for external use - Product Code NAB
  • Causa
    Micro holes were detected in the laminate of the sterile barrier system of sterilized hartmann econolux and hartmann sterilux gauze products.
  • Acción
    The firm, HARTMANN USA, sent an "URGENT: RECALL NOTICE" dated May 14, 2012 to its Consignees/Customers. The notice described the product, problem and actions to be taken. The customers were instructed to examine their inventory, block further shipments of affected items and retrieve additional affected stock from their customers; to confirm initial receipt of the notice by emailing recall@harmanninfo.com; complete and return the Affected Products and Stock Levels form via fax to: HARTMANN USA customer service at (1-803-325-7606); contact customer service to obtain a Returned Goods Authorization; and take adequate measures to ensure this notice is distributed appropriately. If you have any further questions or issues related to this recall, please contact HARTMANN USA customer service or your sales representative at 1-800-243-2294 or email: recall@hartmanninfo.com.

Device

Device Recall Sterilux
  • Modelo / Serial
    Item # 56910000 (Sterilux): 102147399, 102250396, 200105390, 200206394
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Nationwide distribution: USA including states of: AZ, CA, FL, GA, KY, MO, MS, NC, PA, SC, TN, TX, and VA.
  • Descripción del producto
    Hartmann Sterilux Ref 56910000 Sterile Premium gauze sponge 4"x4" 12-ply 24 boxes/case 1200 total sponges || For use in wound cleansing, debriding of wounds, wound packing, covering and swabbing
  • 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