The Recall Desk

FDA (Devices) recall action 68047

Hospira Inc. recalled 2 products on 2014-11-05

The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2014-11-05
Critical
0
Units
978

Why these products were recalled

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.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–2 of 2

  • HighFDA (Devices)··2014-11-05

    Hospira Recalls GemStar Power Supply Due to Power Delivery Failure

    Hospira is recalling GemStar Power Supplies because they may fail to provide direct current power to the infusion pump, potentially causing smoke.

    Product
    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.
    Category
    Distribution
    49 states
  • HighFDA (Devices)··2014-11-05

    Hospira Recalls GemStar Power Supplies Due to Power Delivery Failure

    Hospira is recalling 978 GemStar Power Supplies because they may fail to provide power to the infusion pump, resulting in smoke.

    Product
    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.
    Category
    Distribution
    49 states