Events

Retiro De Equipo (Recall) de Device Recall LifeShield Symbiq 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
    65647
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1751-2013
  • Fecha de inicio del evento
    2013-06-18
  • Fecha de publicación del evento
    2013-07-18
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2016-11-07
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=119808
  • 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
    Hospira has received reports of customers experiencing air-in-line alarms related to administration sets that have a drip chamber with a ball valve. preliminary investigation findings found that there is a potential for the ball valve to not seal the drip chamber as intended, leading to air in the line of the administration set.
  • Acción
    Hospira sent a Urgent Device Recall letter dated June 18, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customer were instructed to check their inventories, quarantine any affected products, complete an attached reply form, and return the product to Stericycle for credit using a label included in the mailing. Customers who further distributed the products are requested to forward the recall notification information to their customers. A 100% effectiveness check will be performed for direct Hospira customers who do not return the reply forms and/or the product. Any direct or indirect accounts that return a reply form indicating they have product but do not return it will also be contacted as part of the effectiveness check. In addition, customers who further distributed the product will be requested to provide confirmation that they have notified their customers who purchased the product. Please contact Hospira Customer Care at 1-877-946-7747 ( M-F 7am - 6pm CT) or your Hospira representative regarding replacement product availability and for questions regarding this recall.

Device

Device Recall LifeShield Symbiq Set
  • Modelo / Serial
    List Number: 19666-04-28;  Lot Number: 87-188-5H
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US (nationwide) including the states of IA, IL, MN, SD and WA., and Costa Rica.
  • Descripción del producto
    LifeShield; Sterile; Rx only; List No. 19666-28; SYMBIQ PUMP SET, CONVERTIBLE PIN, PIGGYBACK, 2 CLAVES PORTS AND OPTION LOK, NON-DEHP; NOMINAL LENGTH: 97 IN (249 CM); PRIMING VOLUME: 14 ML; For the administration of I.V. fluids; Made in Costa Rica; Hospira, Inc., Lake Forest, IL 60045 USA || The Hospira Symbiq Infusion System is a general infusion system which provides IV infusion across the general spectrum of clinical care. The Symbiq pumps are standard sized pumps which are typically facility-based infusion pumps which may be used to deliver continuous and/or intermittent infusions to a variety of patient populations.
  • 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