Events

Recall of Hospira GemStar Docking Station

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Hospira Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    59470
  • Event Risk Class
    Class 2
  • Event Number
    Z-3107-2011
  • Event Initiated Date
    2011-08-01
  • Event Date Posted
    2011-08-31
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-08-29
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=102851
  • Notes / Alerts
    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.
  • Extra notes in the data
    Pump, infusion - Product Code FRN
  • Reason
    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.
  • Action
    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
  • Model / 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
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    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.
  • Product Description
    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.
  • Manufacturer Address
    Hospira Inc., 275 N Field Dr, Lake Forest IL 60045-2579
  • Manufacturer Parent Company (2017)
    Pfizer
  • Source
    USFDA