Recall Z-2031-2014— Hospira Inc.

Name: FDA recall Z-2031-2014
Creator: U.S. Food and Drug Administration
Published: 2014-01-31

Class II · Terminated

Class II FDA medical device recall by Hospira Inc., initiated 2014-01-31, terminated 2016-08-30. It names one FDA 510(k) clearance: K060806. Product: GemStar infusion pump, List numbers 13000 and 13100, GemStar Infusion Pump (pain management) List number 13150. Used for intravenous, arterial, subcutaneous, short-term epidural infusion and parenteral administration of general I.V. fluids, medications, nutritional fluids, and blood/blood products.. Reason: The connection between the beeper subassembly and the pump may fail. The GemStar infusion pump will identify this failure during the "self-test" while powering up which will result in a Beeper Error ("code 10/001/000"). This Beeper Error (code 10/001/000) is a service alarm that places the pump in an inoperable mode and requires service before it can be returned to service..

Recalling firm: Hospira Inc.
Classification: Class II
Status: Terminated
Initiated: 2014-01-31
Terminated: 2016-08-30
Firm location: Lake Forest, IL, United States

510(k) clearances named in this recall

1 on FDA's record

K060806 — HOSPIRA GEMSTAR INFUSION PUMP SYSTEM, 7 THERAPY, MODEL 13087; 6 THERAPY, MODEL 13086; PAIN MANAGEMENT, MODEL 13088Hospira, Inc.·cleared 2006-04-21

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

GemStar infusion pump, List numbers 13000 and 13100, GemStar Infusion Pump (pain management) List number 13150. Used for intravenous, arterial, subcutaneous, short-term epidural infusion and parenteral administration of general I.V. fluids, medications, nutritional fluids, and blood/blood products.

Reason for recall

The connection between the beeper subassembly and the pump may fail. The GemStar infusion pump will identify this failure during the "self-test" while powering up which will result in a Beeper Error ("code 10/001/000"). This Beeper Error (code 10/001/000) is a service alarm that places the pump in an inoperable mode and requires service before it can be returned to service.

Data sourced from openFDA. This site is unofficial and independent of the FDA.