Events

Retiro De Equipo (Recall) de Hospira Plum A3 I.V. infusion pump

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
    29982
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0439-05
  • Fecha de inicio del evento
    2004-09-08
  • Fecha de publicación del evento
    2005-01-27
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2005-09-20
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=34907
  • 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
    Ph Rate Measurement, Carbon-Dioxide - Product Code JFL
  • Causa
    The batteries in plum a+ and plum a+3 i.V. infusion pumps may fail prematurely when the pump is operating solely on battery power.
  • Acción
    On 9/8/04, all consignees were notified via written letter sent via Federal Express, informing them of the affected products and providing instructions on the recall. The firm will follow up with phone calls to its consignees.

Device

Hospira Plum A3 I.V. infusion pump
  • Modelo / Serial
    The following LIST numbers are under recall. All lots (serial numbers) are currently under recall. LIST No. 12618-04 and LIST No. 12348-04.
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    The firm distributed these products to 484 consignees throughout the US, and an undetermined number of foreign consignees. The firm has distributed the product nationwide, excluding AK, HI, NV, NM, SC, and SD. The firm has sent products to Veterans Supply Office Pharmacy, Dept. of Veteran''s Affairs, Vet Admin Medical Center and US Pentitentiary-MC. Foreign countries that have received the product incluide Saudi Arabia, Canada, Puerto Rico and Taiwan.
  • Descripción del producto
    The Hospira Plum A+3 I.V. Infusion pump is a cassette-based, multi-function fluid delivery infusion system, consisting of pumping module and assortment of IV sets.
  • Manufacturer
    Hospira Inc

Manufacturer

Hospira Inc
  • Dirección del fabricante
    Hospira Inc, 755 Jarvis Dr, Morgan Hill CA 95037-2810
  • Source
    USFDA