Recall Z-0095-2015 ยท FRN Pump, Infusion
Hospira Inc.
The GemStar Power Supply is an accessory for the GemStar Infusion Pump. It is a two piece assembled switching power supply. The Power Supply converts alternating current (AC) line input voltage of 120 or 240 V to an output to the device of 3.3 Volts DC.
| Date | Oct 24, 2014 (initiated Feb 3, 2014) |
| Status | Terminated |
| Reason | The GemStar Infusion pump may not receive direct current (DC) power from the power supply. In one instance, smoke was observed and the GemStar pump was operating on battery power while connected to the 3 volt DC power supply. |
| Root cause | Process control |
| Action | An URGENT MEDICAL DEVICE CORRECTION letter dated February 3, 2014 was sent to all direct accounts. The letter included specific instructions for how to handle and use the power supplies so as to minimize the chance of any device failures. There were additional instructions for customers to: 1) Inform potential users in their organization of the product of this notification; 2) Complete the attached reply form and return it to the fax number or e-mail address on the form (even if you do not have any affected product in inventory); 3) If the products were further distributed, their customers s |
| Quantity | 978 power supplies |
| Distribution | Worldwide Distribution -- USA, including the states 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, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY; and, the countries of Austria, Belgium, Brazi |
| 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 |