Events

Retiro De Equipo (Recall) de Device Recall Bur Hypo Pack

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 Novomedicus Llc.

¿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
    60844
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0920-2012
  • Fecha de inicio del evento
    2011-06-22
  • Fecha de publicación del evento
    2012-01-27
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-08-28
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=106737
  • 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
    On 06/22/2011 novomedicus, fl initiated a recall of the artificial bur hypopack lot 1010.1, 1102.1, 1103.1 and 5643.2. cytotoxicity testing revealed a biocompatibility issue. the test results did not represent a health risk.
  • Acción
    Novomedicus sent a Medical Device Correction letter dated June 22, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to destroy the inventory, or return the inventory to Novomedicus. If customers decided to return the remaining inventory, Novomedicus would provide TWO replacement kits for each one returned at no additional cost. Customers were asked to complete the attached Return Response form and return to NovoMedicus using the self-addressed and stamped envelope included. For questions regarding this recall call 941-375-4108.

Device

Device Recall Bur Hypo Pack
  • Modelo / Serial
    Lots: 1010.0, 1102.1, and 1103.1
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Wordwide Distribution - USA including IL, AZ, PA, CT, MO, WI, NY, TX, OR, ME, FL, VA, and MS and the countries of Mexico and Qatar.
  • Descripción del producto
    The Artificial Bur HypoPack is a Temporary Fascial Prothesis with Hypobaric Wound Dressing. For Single Patient Use only. || Contents: 1. Large Bur Patch (Sterile: EO), 20cm x 40cm Loop Sheet, 20cm x 40cm Hook Sheet. || 2. 60cm x 85 cm Steri Drape || 3. Drain with Connector || 4. 4 x Gauze Rolls || Sterile: Contents are sterile for maximum two years unless enclosed package has been opened or damaged. || Used for a fascia expander prosthesis to temporarily close the abdominal cavity when regular abdominal closure is not possible; to prevent perfusion impairment of abdominal organs from increases intra-abdominal pressure; and for advanced intra-abdominal pathology requiring more than one abdominal operation to control the disease process.
  • Manufacturer
    Novomedicus Llc

Manufacturer

Novomedicus Llc
  • Dirección del fabricante
    Novomedicus Llc, 990 Gulf Winds Way, Nokomis FL 34275-3363
  • Source
    USFDA