Events

Retiro De Equipo (Recall) de Skin Staple Removal

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 Customed, 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
    69448
  • Clase de Riesgo del Evento
    Class 1
  • Número del evento
    Z-0250-2015
  • Fecha de inicio del evento
    2014-10-08
  • Fecha de publicación del evento
    2014-12-16
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-08-14
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=130669
  • 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
    Staple, removable (skin) - Product Code GDT
  • Causa
    Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.
  • Acción
    Customed initiated a recall on October 8th, 2014 of sterile convenience surgical Packs-trays, bags (known as Convenience Packs) and new lots of products added to the initial June 3, 2014 recall of 233 sterile surgical packs. The products are being recalled because of significant compromised sterility, not limited to potentially damaged packaging. Customers were instructed to quarantine and cease use of the affected product identified. Customers are to return the response form included with the letter, to the contact information provided. Upon receipt, the firm will contact customers with further instructions to obtain credit, replacement product, and for return of the recalled product or any other disposition action. If customers have any questions, they should contact the Customed Recall Coordinator at 407-850-5558 extensions 8001 or 8005, or via e-mail: pablo.diaz@customedhealing.com.

Device

Skin Staple Removal
  • Modelo / Serial
    Lot numbers: 111112954 111112965 111123297 111123444 112010204 112020511 112030694 112051651 112052014 112083064 112093637 112104287 112114538 112124884 113025834 113026068 113036743 113047031 113057506 113067936 113067964 140111127 140312184 140513161 140613781 140814822 1130688891
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    US Distribution to Florida, New York and Puerto Rico..
  • Descripción del producto
    Skin Staple Removal, Catalog number 900-782. || Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
  • Manufacturer
    Customed, Inc

Manufacturer

Customed, Inc
  • Dirección del fabricante
    Customed, Inc, Calle Igualdad Final #7, Fajardo PR 00738
  • Empresa matriz del fabricante (2017)
    Customed Inc
  • Source
    USFDA