Events

Retiro De Equipo (Recall) de Device Recall PolyglycolicLactic Acid Absorbable Surgical Suture

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 Riverpoint Medical, 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
    65584
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0347-2014
  • Fecha de inicio del evento
    2012-12-13
  • Fecha de publicación del evento
    2013-11-18
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-11-21
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=119650
  • 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, surgical, absorbable, polydioxanone - Product Code NEW
  • Causa
    Riverpoint medical is recalling pgla surgical suture (vilet) because the label indicates the suture is undyed and it is actually a violet colored suture.
  • Acción
    Riverpoint sent an Urgent Medical Device Recall letter in December 2012 to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were requested to review their inventory and immediately quarantine the product in question, if found. In addition, if they have further distributed the recalled product, the consignees were advised to identify their customers and notify them of this product recall. All affected product is to be returned to Riverpoint Medical. Consignees were asked to call 503-517-8001 to return recalled product and request a credit or replacement. For questions regarding this recall call 503-517-8001.

Device

Device Recall PolyglycolicLactic Acid Absorbable Surgical Suture
  • Modelo / Serial
    Lot 120716-01
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    US Distribution in the states of: AZ, FL, and TX.
  • Descripción del producto
    Polyglycolic-Lactic Acid Absorbable Surgical Suture || Label reads in part "Coated VILET *** (Polyglacin 910) Suture UNDYED BRANDED V423 *** Riverpoint ***" || PGLA surgical suture is indicated for use in general soft tissue approximation and/or ligation, including use in opthalmic procedures, but not for use in cardiovascular and neurological tissues
  • Manufacturer
    Riverpoint Medical, LLC

Manufacturer

Riverpoint Medical, LLC
  • Dirección del fabricante
    Riverpoint Medical, LLC, 825 NE 25th Ave, Portland OR 97232-2304
  • Empresa matriz del fabricante (2017)
    Riverpoint Medical LLC
  • Source
    USFDA