Recall Z-2031-2014 · FRN Pump, Infusion

Hospira Inc.

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.

Date	Jul 10, 2014 (initiated Jan 31, 2014)
Status	Terminated
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.
Root cause	Component design/selection
Action	Hospira sent an URGENT MEDICAL DEVICE RECALL letter dated January 31, 2014 was sent to all affected customers. The letter included instructions for customers to: 1) inform potential users of these devices of the notification, 2) if the beeper error occurs during power up, remove the device from service immediately, 3) report any beeper errors to Hospira by calling 800-441-4100 (Monday - Friday, 8:00 AM - 5:00 PM CST) or e-mail ProductComplaintsPP@hospira.com, 4) complete the attached reply form and return it to the fax number of e-mail address on the form (even if there is no product in inven
Quantity	36,881 infusion pumps
Distribution	Worldwide Distribution - US: Nationwide in the state of 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 including District Of Columbia, Guam, Puerto
FDA record	Open on fda.gov

510(k) clearances named in this recall

K060806

HOSPIRA GEMSTAR INFUSION PUMP SYSTEM, 7 THERAPY, MODEL 13087; 6 THERAPY, MODEL 13086; PAIN MANAGEMENT, MODEL 13088
Hospira, Inc., Apr 21, 2006