Home / Recalls / Hospira Inc. / Z-0096-2015

Z-0096-2015 Class I Terminated

Recalled by Hospira Inc. — Lake Forest, IL

FDA device recall Z-0096-2015 was initiated by Hospira Inc. on Feb 3, 2014 and is designated Class I. Reason for recall: 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 recall status is terminated (terminated Mar 7, 2017). Affected quantity: US Distribution: 4,709 power supplies; Foreign Distribution: 7,425 power supplies.

Recall Details

Product Type: Devices
Report Date: Nov 5, 2014
Initiation Date: Feb 3, 2014
Termination Date: Mar 7, 2017
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: US Distribution: 4,709 power supplies; Foreign Distribution: 7,425 power supplies

Product Description

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.

Reason for Recall

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.

Distribution Pattern

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, Brazil, Columbia, France, Germany, Greece, Netherlands, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, Turkey, and United Kingdom.

Code Information

Desktop GemStar Power Supply List Number: 13072-05; 1) US Distribution Lot Numbers: 10115G1, 11121G1, 11122G1, 1123G1, 11124G1, 12143G1, 12144G1, 12178G1, 15185G1, 12195G1, 17214G1, 18217G1, 18219G1, 19225G1, 20233G1, 21242G1, 22251G1, 23259G1, 24271G1, 25280G1, 26289G1, 26290G1, 27293G1, 27297G1, 27300G1; 2) Foreign Distribution Lot Numbers: 11128G1, 12140G1, 12142G1, 12148G1, 14176G1, 15187G1, 15196G1, 16207G1, 16208G1, 18218G1, 19226G1, 19229G1, 20234G1, 21241G1, 22255G1, 23262G1, 24270G1, 25276G1, 26285G1, 27299G1, 27301G1

Source

Dataset: openFDA device recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for Z-0096-2015
openFDA file date: Oct 27, 2026
Loaded by RegDataLab: Oct 29, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.

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