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FDAFDA · Alimentos y medicamentos·N.º oficial Z-0096-2015

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.

Publicado el 5 de noviembre de 2014 · Inicio del retiro: 3 de febrero de 2014

Estado reportado al momento de publicación: Terminated — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.

Qué peligro representa

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.

Qué hacer

Voluntary: Firm initiated · Letter

Detalles del retiro

Fabricante
Hospira Inc.
Distribuidor
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.
Lote
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
Clasificación de riesgo
Class I
Área (FDA)
device
País
United States

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