Events

Retiro De Equipo (Recall) de Device Recall AMS 4674 Custom Pack

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 Windstone Medical Packaging, 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
    72604
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0376-2016
  • Fecha de inicio del evento
    2015-11-02
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2016-08-17
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=141641
  • 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
    Kit, surgical instrument, disposable - Product Code KDD
  • Causa
    Ams 4674 custom pack is recalled because this kit containing u-sdn 2 part ultra modified seldinger needle which is recalled by supplier.
  • Acción
    Aligned Medical Solutions (AMS) sent the Procedure Products -Urgent Medical Device Recall Letter, dated November 02, 2015 to consignees. This letter listed the items affected by recall as: AMS 4674 Custom Pack and AMS 4675 Angio Pack. Both direct account and sub account are informed that the part # NS/37 -0387 01 U-SDN 2 Part Ultra Modified Seldinger Needle (introducer needle) is recalled because some was unable to accept guide wires up to .038" as intended. The inner diameter was found to be out of specification in some cases. All other components in these two AMS kits are not affected by this recall. Customers with questions about this recall can call Vicki Davis at 321-527-7714 or send email to vdavis@alignedmedicalsolutions.com.

Device

Device Recall AMS 4674 Custom Pack

Manufacturer

Windstone Medical Packaging, Inc.
  • Dirección del fabricante
    Windstone Medical Packaging, Inc., 1602 4th Ave N, Billings MT 59101-1521
  • Empresa matriz del fabricante (2017)
    Windstone Medical Packaging Inc.
  • Source
    USFDA