Retiro De Equipo (Recall) de Integra Kits for Epidural Anesthesia Administration

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 Integra LifeSciences Corp. d.b.a. Integra Pain Management.

¿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
  • ID del evento
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
  • Fecha de inicio del evento
  • Fecha de publicación del evento
  • Estado del evento
  • País del evento
  • Fecha de finalización del evento
  • Fuente del evento
  • 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
    Anesthesia conduction kit - Product Code CAZ
  • Causa
    Integra lifesciences corporation is recalling certain lots of integra kits for epidural anesthesia administration as a result of a product advisory notice from bd medical for the lor syringes indicating the plunger of the syringe may stall or stick when travelling within the syringe.
  • Acción
    BD Medical sent a Product Advisory Notice letter dated August 23, 2013 to Iaffected consignees by via traceable courier. The letter identified the affected product, problem and actions to be taken. Distributor have been asked to forward copies of the notification to their customers. For questions call BD Customer Service at 1-888-237-2762.


  • Modelo / Serial
    Kit Cat No: 10-2433,13-2595,13-2616,13-2628,3104195,3403061,3403150,3403316,3403579,3403727,3403776,3403813,3403989,3404131,3404269,3404293,3404417,3404468,3404578,3503559,CUS025,CUS1121-01,CUS1164-02,CUS1202-04,CUS1298-03,CUS1376,CUS1376,CUS1400-01,CUS1406-03,CUS1415-04,CUS1568-01,CUS1664-01,CUS1696,CUS1723,CUS1760,CUS1773-01,CUS1797,CUS279-02,CUS416,CUS597,CUS628-02,CUS755,PISLL7,RSM394,RSM395,SS1246,SS2036-01,
  • Clasificación del producto
  • Clase de dispositivo
  • ¿Implante?
  • Distribución
    USA Nationwide Distribution and one foreign consignee in Mursalat.
  • Descripción del producto
    Integra Disposable, Convenience Kit Single Shot Epidural Tray Reorder Number 340269 Rx Only || Product Usage: || The Integra kits which contain a BD LOR syringe are intended to provide licensed medical professionals with a kit containing drugs and other medical devices that are used to support the administration of general, local or spinal anesthetics. The BD LOR syringe is intended for use, in conjunction with an epidural needle, to verify the needle tip placement is in the epidural space by use of the Loss of Resistance Technique as detailed in medical textbooks and medical journal articles. The LOR Syringe is not intended for injection or aspiration.
  • Manufacturer


  • Dirección del fabricante
    Integra LifeSciences Corp. d.b.a. Integra Pain Management, 3498 West 2400 South #1050, Salt Lake City UT 84119
  • Empresa matriz del fabricante (2017)
  • Source