Retiro De Equipo (Recall) de Device Recall InVisionPlus CS Needleless IV Connector

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 Rymed Technologies, 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
    72997
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0676-2016
  • Fecha de inicio del evento
    2016-01-05
  • Fecha de publicación del evento
    2016-01-21
  • Estado del evento
    Terminated
  • País del evento
  • Fecha de finalización del evento
    2016-10-19
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
  • 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
    Set, administration, intravascular - Product Code FPA
  • Causa
    Potential for the female luer component of the invision-plus iv connector to crack during use.
  • Acción
    The firm Ry Med Technology LLC, sent an "URGENT: MEDICAL DEVICE RECALL" letter dated January 4, 2016 and response form to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to discontinue use and return the product to: RyMed Technologies LLC, 6000 W. William Cannon Drive, Building B, Suite 300 Austin, TX 78749; the user facilities to change the IV connectors in 24 hour when lipids are being administered; if further distributed, contact other accounts, advise of recall and return outstanding stock; complete and return the RECALL NOTIFICATION ASAP and no later than 10 business day via email to: amccutchen@rymedtech.com, fax to: 512-301-7338, Attention Recall Return Notification or mail to RyMed Technologies LLC, Attention Recall Return Notification, 6000 W. William Cannon, Building B, Suite 300 Austin, TX 78749. If you have any questions concerning the recall, contact Director of Quality Assurance/Regulatory Affairs by email to: amccutchen@rymedtech.com or call 512-301-7338x303. If you have questions about returning/replacement of product contact Logistics Specialist by email to: svara@rymedtech.com or call 512-301-7338x309.

Device

  • Modelo / Serial
    Catalog number RYM-7001 Lots: R01842, R01889, R01891, and R01897, Expire 03/2016.
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    US Nationwide Distribution.
  • Descripción del producto
    InVision-Plus CS Needleless IV Connector, Catalog Number RYM-7001. Disposable, Single Use. || Products are intended for single patient use in intravenous and blood administration sets without the need for needles, thus eliminating the potential for needle-stick injuries during use.
  • Manufacturer

Manufacturer

  • Dirección del fabricante
    Rymed Technologies, LLC, 6000 W William Cannon Dr Ste B300, Austin TX 78749-1991
  • Source
    USFDA