The Recall Desk

FDA (Devices) recall action 64832

Hospira Inc. recalled 2 products on 2013-11-27

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
2013-11-27
Critical
0
Units
43,840

Why these products were recalled

The proximal and distal pressure sensor calibration can drift resulting in the pump failing the Proximal or Distal Occlusion Operational Test, as described in the GemStar Technical Service Manual, or reporting one of the following errors during device setup or infusion: 1) Cassette Check - D; 2) Cassette Check - P; 3) Proximal Occlusion; 4) Distal Occlusion; 5) Pressure Calibration Error; 6) Bad Pressure Sensor Event; 7) Bad Pressure State; 8) Distal Pressure is Out of Range; 9) Proximal Sensor is Out of Range. A pump with this issue may, instead of reporting an error, …

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)··2013-11-27

    Hospira Recalls GemStar Infusion Pumps Due to Pressure Sensor Calibration Drift

    Hospira is recalling GemStar infusion pumps because pressure sensor calibration drift may cause the device to fail occlusion tests or report false errors.

    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
    51 states
  • HighFDA (Devices)··2013-11-27

    Hospira Recalls GemStar Infusion Pumps Due to Pressure Sensor Calibration Drift

    Hospira is recalling 43,840 GemStar infusion pumps worldwide because pressure sensor calibration drift may cause the device to fail occlusion tests or issue false alarms.

    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
    51 states