Events

Retiro De Equipo (Recall) de Hospira GemStar Docking Station

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
    59470
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-3107-2011
  • Fecha de inicio del evento
    2011-08-01
  • Fecha de publicación del evento
    2011-08-31
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2016-08-29
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=102851
  • 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
    Pump, infusion - Product Code FRN
  • Causa
    Hospira has received reports of sparking, smoking, charring and electrical shock when using the gemstar docking station due to fluid ingress into the docking station.
  • Acción
    Hospira Inc. sent an "URGENT DEVICE FIELD CORRECTION" letter dated August 1, 2011 to all affected customers. The letter describes the product, problem, and the actions to be taken by the customers. The requests that customers do not hang or place fluid containers over the docking station, not spray fluid directly on the docking station, and to clean the docking station using a cloth dampened with an apporoved cleaning solution. A reply form was attached to the letter for customers to complete and return via fax at 262-577-6921. Contact Hospira at 1-800-441-4100 for questions concerning this notice. *** Hospira sent an update letter dated September 26, 2012 to the accounts, informing them of the availability of the improved design replacement docking stations, and requesting them to complete and return the enclosed reply via fax or e-mail to Hospira, indicating the number of docking stations to be returned for replacement at no charge if the old docking stations are returned within 45 days of receipt of the replacement stations. ***

Device

Hospira GemStar Docking Station
  • Modelo / Serial
    List Number 13075-04-01, batch numbers 15047G1, 15048G1, 15050G1, 17100G1, 19140G1, 19142G1, 19157G1, 20165G1, 20180G1, 21183G1, 21196G1, 21197G1, 62001L2, 63001L2, 68002L2, 69002L2, 73002L2 and 78001L2; List Number 13075-04-03, batch numbers 26289G1, 27314G1, 27324G1, 30375G1, 34499G1, 34601G1, 34603G1, 34605G1, 34606G1, 34608G1, 35615G1, 40764G1, 40765G1, 40766G1 and 41804G1; List Number 13075-04-05, batch numbers 41802G1, 44848G1, 44854G1, 45879G1, 45879G101, 45879G1R, 45884G1, 46910G1, 47916G1, 47936G1, 48960G1, 51031G1, 51032G1, 60285G1, 84824G1, 84827G1, 84831G1 and 85844G1;  List number 13075-04-07, batch numbers 75679G1, 7698G1, 77698G101, 77715G1, 77715G101, 78734G1, 80774G1, 81784G1, 82789G1 and 87880G1;  List number 13075-24-01, batch numbers 10899G1, 10910G1, 10917G1, 10930G1, 14010G1, 15046G1, 16060G1, 19141G1, 19144G1, 19145G1, 19146G1, 19147G1, 19148G1, 19149G1, 20171G1, 21191G1, 21203G1, 26289G1, 64001L2, 68001L2, 69001L2, 71001L2 and 73001L2;  List number 13075-24-03, batch numbers 26289G1, 26294G1, 27325G1, 31397G1, 35620G1, 35621G1, 36634G1, 36636G1, 36638G1, 37667G1, 39739G1, 41786G1, 54114G1, 74001L2, 78002L2, 80001L2, 82001L2, 85308G1, 86319G1, 87340G1, 88358G1, 88366G1, 90442G1 and 92486G1; List number 13075-24-05, batch numbers 19141G1, 45878G1, 47915G1, 48961G1, 50020G1, 51021G1, 51022G1, 51028G1, 51030G1, 53081G1, 53082G1, 54098G1, 54113G1, 54114G1, 55125G1, 55126G1, 55135G1, 56158G1, 56170G1, 59230G1, 59231G1, 60258G1, 60272G1, 60284G1, 61307G1, 63318G1, 64345G1, 64354G1, 73634G1, 73636G1, 74647G1, 84828G1, 84828G1R, 84830G1 and 84830G1R;  List number 130752407, batch numbers 75680G1, 75681G1, 75682G1, 76686G1, 77694G1, 77694G1R, 77695G1, 77695G1R, 77696G1, 77697G1, 77712G1, 77712G1R, 77713G1, 77714G1, 78735G1, 78735G1R, 78736G1, 78736G1R, 78737G1, 80775G1, 80775G1R, 82799G1, 82799G1R, 82802G1, 82802G1R, 93962G1, 93962G1R, 94973G1, 94973G1R, 95981G1, 95981G1R, 95985G1, 95985G1R, 96004G1, 96004G1R, 96989G1, 96989G1R, 96996G1, 96996G1R, 97013G1, 97013G1R, 97017G1 and 97017G1R
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution-USA (nationwide) and the countries of Australia, Belgium, Canada, Chile, France, Germany, Hong Kong, Ireland, Italy, Japan, Jordan, the Netherlands, Portugal, Saudi Arabia, Singapore, Spain, Sweden and Switzerland.
  • Descripción del producto
    GemStar Li-Ion Docking Station; a lithium ion battery powered docking station for use with GemStar Infusion Pumps; Hospira, Inc., Lake Forest, IL 60045; List Numbers 13075-04-01, 13075-04-03, 13075-04-05, 13075-04-07, 13075-24-01, 13075-24-03, 13075-24-05 and 13075-24-07, Note: list numbers with xxxxx-04-xx are for U.S., Canada, Japan, Netherlands and Singapore, while those with xxxxx-24-xx are for international distribution only. || The docking station for the GemStar pump is used to provide an alternate power source, acting either as a direct current battery backup, or as an alternating current power source when the docking station is plugged into AC power. The docking station also serves as a stand in which to place the GemStar during pump operation.
  • 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