The Recall Desk

FDA (Devices) recall action 64839

Hospira Inc. recalled 2 products on 2013-05-08

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
2013-05-08
Critical
0
Units
—

Why these products were recalled

Battery level lower then 2.4 volts results in corrupt history log and loss of data for preview therapy's parameters and causes an 11/004 error resulting in the pump not being able to be used.

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

1–2 of 2

  • SevereFDA (Devices)··2013-05-08

    Hospira Recalls GemStar Infusion Pumps Due to Battery Data Loss

    Hospira Inc. is recalling GemStar infusion pumps because low battery levels can corrupt history logs and cause an error that prevents the device from being used.

    Product
    GemStar Pump - Battery Product Usage: The GemStar Pump is a small and lightweight, single channel infusion device designed for use in the home, in the hospital, or anywhere electronic infusion is required. The GemStar Pump can be powered by AC mains adaptor, rechargeable b
    Category
    Distribution
    0 states
  • SevereFDA (Devices)··2013-05-08

    Hospira Recalls GemStar Infusion Pumps Due to Battery Data Loss

    Hospira is recalling GemStar infusion pumps because low battery levels can corrupt data and cause an error that prevents the device from being used.

    Product
    GemStar Pump - Battery Product Usage: The GemStar Pump is a small and lightweight, single channel infusion device designed for use in the home, in the hospital, or anywhere electronic infusion is required. The GemStar Pump can be powered by AC mains adaptor, rechargeable bat
    Category
    Distribution
    0 states