Events

Retiro De Equipo (Recall) de Device Recall Bondek Absorbable Sutures

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 Telefelx Medical.

¿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
    54474
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2286-2010
  • Fecha de inicio del evento
    2010-02-01
  • Fecha de publicación del evento
    2010-08-26
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-04-19
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=88544
  • 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
    Suture, absorbable, synthetic, polyglycolic acid - Product Code GAM
  • Causa
    Labeling error; the bondek suture product inside the box are of a different catalog number than labeled on the outer box.
  • Acción
    Teleflex Medical issued consignees a "Urgent Medical Device Recall" letter dated February 1, 2010. Distributors were instructed to forward the letter to their consignees to retrieve relevant product from those locations. The letter described the packaging issue and potential impact. Customers were instructed to immediately discontinue use and quarantine any identified products, complete and fax the Recall Acknowledgement Form to 866-804-9881, in order to receive a Return Goods Authorization (RGA) Number, and then return the product to Teleflex Medical for replacement. Affected products received by Teleflex Medical will be destroyed upon receipt.

Device

Device Recall Bondek Absorbable Sutures
  • Modelo / Serial
    Catalog Number: EP4084N, Lot number: 02A0801449
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Worldwide Distribution: USA and Germany
  • Descripción del producto
    Deknatel Bondek¿ Plus Polyglycolic Absorbable Surgical Sutures, Bon+BG BR 3-0 DSL 19 1N (45cm), Teleflex Medical. Bondek and Bondek Plus Synthetic Absorbable Surgical Sutures intended uses are in general surgical procedures where general soft tissue approximation and/or ligation are performed, including use in ophthalmic procedures, but not for use in cardiovascular and neurological procedures.
  • Manufacturer
    Telefelx Medical

Manufacturer

Telefelx Medical
  • Dirección del fabricante
    Telefelx Medical, 2917 Weck Drive, Durham NC 27709
  • Empresa matriz del fabricante (2017)
    Teleflex Incorporated
  • Source
    USFDA