Events

Recall of Device Recall 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
    67802
  • Event Risk Class
    Class 1
  • Event Number
    Z-1512-2014
  • Event Initiated Date
    2014-02-18
  • Event Date Posted
    2014-05-01
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-01-23
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=126354
  • 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
    There are two situations that may occur when using the gemstar docking station, list number 13075-xx-xx, in conjunction with the gemstar infusion pump: 1) when the docking station is used in conjunction with a gemstar phase 3 pump (list 13000-xx, 13100-xx, or 13150-xx) the potential exists for the gemstar phase 3 pump to fail to power up while connected to the docking station, and 2) when either a gemstar phase 3 (list 13000-xx, 13100-xx, or 13150-xx)or gemstar phase 4 pump (list 13086-xx, 13087-xx, or 13088-xx) is used in conjunction with both a docking station and an external battery pack accessory (list 13073-xx) there exists a possibility that the gemstar pump will display error code 11/003 and give an audible alarm indicating excessive input voltage from the external sources. if the gemstar pump detects what is perceived to be more than 3.6 volts measured on the external voltage input, the pump will stop the infusion and alarm both with an audible sound as well as a visual alarm.
  • Action
    Hospira sent an URGENT MEDICAL DEVICE CORRECTION letter dated February 18, 2014, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. The letter included the following instructions: 1) To avoid failure to power up, turn the pump on first, before connecting the pump with the docking station. This will prevent the failure to power up. 2) To mitigate the potential for an 11/003 error code, remove the External Battery Pack accessory (List 13073) from the Docking Station in conjunction with an External Battery Pack accessory (List 13073), this practice should not continue. Please contact Hospira to discuss an appropriate alternative. Additional instructions included: 1) Inform potential users within the recipient's organization of the notification. 2) Should the facility experience a failure to power up or an 11/003 error code, report the issue to Hospira by calling 1-800-441-4100 (Monday - Friday, 8:00 AM - 5:00 PM CT) or e-mail ProductComplaintsPP@hospira.com. 3) Compelte the attached reply form and return it to the fax number or e-mail address on the firm, even if there is no affected product in inventory. 4) If th products were further distributed, notify the accounts that received the products identified in the notification and ask them to contact Steriycle at 866-792-5451 (Monday - Friday, 8:00 AM - 5:00 PM ET) to receive a reply form. For questions regarding this recall call 800-441-4100.

Device

Device Recall GemStar Docking Station
  • Model / Serial
    *** US DOCKING STATIONS ***   List Numbers: 13075-04-01, 13075-04-03, 13075-04-05, 13075-04-07, 13075-04-09.   *** FOREIGN DOCKING STATIONS ***   List Numbers: 13075-24-01, 13075-24-03, 13075-24-05, 13075-24-07, 13075-92-09.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA including AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, District of Columbia, Guam, Puerto Rico, and Internationally to Australia, Austria, Bahrain, Belgium, Canada, Chile, Egypt, France, Germany, Greece, Hong Kong, Italy, Jordan, Kuwait, Lebanon, Libya, Luxemburg, Netherlands, New Zealand, Oman, Portugal, Saudi Arabia, Slovenia, South Africa, Spain, Switzerland, Turkey, United Arab Emirates, and United Kingdom.
  • Product Description
    GemStar Docking Station, used with GemStar infusion pump, in combination with other GemStar accessories such as the GemStar Lock Box and patient bolus cord. The docking station is also used for hosting the GemStar pump for general infusions. List Numbers: 13075-XX-XX.
  • 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