Events

Retiro De Equipo (Recall) de Gemstar Pump Set

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 Hospira 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
    56505
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2627-2010
  • Fecha de inicio del evento
    2010-08-12
  • Fecha de publicación del evento
    2010-09-29
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-06-21
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=93799
  • 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.
    ICU Medical, Inc. acquired from Pfizer in early 2017, Hospira Infusion Systems, the portion of Hospira dedicated to develop infusion pumps.
  • Notas adicionales en la data
    Set, administration, intravascular - Product Code FPA
  • Causa
    Underdelivery of infusion during clinical use at low rate settings (less than 10 ml/hour). patient may not receive the intended amount of medication.
  • Acción
    Hospira issued Urgent Device Recall letters dated August 12, 2010 to Hospira's direct accounts, informing them of the potential for under delivery under low rate settings using the affected lots of pump sets. The accounts were instructed to examine their inventory for the affected product, quarantine it immediately, and complete the attached reply form indicating the amount of product being returned, faxing it to Stericycle at 1-877-523-9110. If they distributed the affected product further, they were instructed to sub-recall the product from their sub-accounts. Accounts may contact Hospira Customer Care at 1-877-946-7747 or their Hospira Account Manager to obtain replacement product. For medical inquiries, the accounts were directed to contact Hospira Medical Communications at 1-800-615-0187. Customers may contact Stericycle, which is managing this recall, at 877-274-7163 for further information concerning this recall.

Device

Gemstar Pump Set
  • Modelo / Serial
    list number 12640-01, lot numbers 682105H and 770815H
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution: USA, (all states), and the countries of Canada, Costa Rica and Taiwan.
  • Descripción del producto
    Gemstar Pump Set, Latex-Free Extension Set with Integral Pressure-Activated Anti-Siphon Valve and Y-Extension with Backcheck Valve-SL, Nonvented, 110 inch; Rx, sterile, 24 individually packaged sets per case; Hospira, Inc., Lake Forest, IL 60045 USA, Made in Costa Rica; list number 12640-01
  • Manufacturer
    Hospira Inc.

Manufacturer

Hospira Inc.
  • Dirección del fabricante
    Hospira Inc., 275 N Field Dr, Lake Forest IL 60045-2579
  • Empresa matriz del fabricante (2017)
    Pfizer
  • Source
    USFDA