FDAFDA · Food and drugs·Recall number Z-0095-2015
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.
Published November 5, 2014 · Recall initiated: February 3, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Hospira Inc.
- Distributor
- 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.
- Lot
- Wall Mount GemStar Power Supply List Number: 13026; Lot Numbers: 25283G1, 26286G1, 26287G1, 27292G1, 27294G1, 27295G1, 27296G1
- Risk classification
- Class I
- Area (FDA)
- device
- Country
- United States
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