The Recall Desk

FDA (Devices) recall action 64837

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
1
Units

Why these products were recalled

Pump shutting off during use without warning.

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

1–2 of 2

  • CriticalFDA (Devices)··2013-05-08

    Hospira Recalls GemStar Infusion Pumps Due to Unexpected Shutdowns

    Hospira Inc. is recalling GemStar infusion pumps because they may shut off during use without warning, potentially interrupting patient medication delivery.

    Product
    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 battery pack, docking station, or two disposab
    Category
    Distribution
    0 states
  • SevereFDA (Devices)··2013-05-08

    Hospira GemStar Infusion Pumps Recalled for Unintended Shutdowns

    Hospira Inc. is recalling GemStar infusion pumps because they may shut off during use without warning. The recall affects pumps distributed worldwide.

    Product
    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 battery pack, docking station, or two disposab
    Category
    Distribution
    0 states