Hospira Inc., GemStar Infusion System, Lithium Battery - Low Voltage

Recall Class: Class I

Date Recall Initiated: March 18, 2013

Product: GemStar Infusion System

All GemStar Infusion Systems are affected by this recall.

Models: 13000, 13100, 13150, 13086, 13087, 13088

Manufacturing and Distribution Dates: February 1999 through April 2013

The GemStar Infusion System is a small, lightweight, single-channeled device designed for use in the home, hospital or anywhere electronic infusion is required. The device is intended for use in intravenous, arterial, subcutaneous, short-term epidural infusion and parenteral administration of general I.V. fluids, medications, nutritional foods and blood/blood products.

Recalling Firm:
Hospira, Inc.
275 North Field Drive
Lake Forest, Illinois 60045-2579

Reason for Recall:

Battery failure resulting in delay/interruption of therapy and loss of data.

When the GemStar Lithium battery voltage level drops below 2.4 volts, an "11/004" error is displayed and the device is rendered inoperable. This failure mode results in a delay/interruption of therapy. Additionally, infusion settings and event history logs will be erased as a result of this device malfunction.

The severity of the clinical impact, due to the delay/interruption in therapy, is dependent upon the underlying condition of the patient and the treatment being prescribed. A delay/interruption in therapy has a worst case potential to result in a significant injury or death.

Health care professionals are advised to weigh the risk/benefit to patients associated with the use of the device when administering critical therapies. Customers should consider the use of an alternative product, particularly in patients in which a delay/interruption in therapy could result in significant injury or death.

Public Contact: For additional information or technical assistance, contact Hospira Advanced Knowledge Center at 1-800-241-4002, option 4, 24 hours a day/7 days a week.

FDA District: Chicago District Office

Additional Recall Information:
On March 18, 2013, Stericycle, Inc., on behalf of Hospira, Inc., notified customers of the problem by UPS-delivered customer notification letter with a return reply form. Customers were asked to complete the reply form and return it to the fax number or e-mail address on the form even if they do not currently have the impacted devices.