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.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a defect that could lead to failure to detect occlusions or false alarms, posing a risk of harm to patients, but no injuries or illnesses are reported in the source text.
Plain-English summary
Hospira Inc. is recalling 43,840 GemStar infusion pumps distributed worldwide, including in the United States and numerous international markets. The GemStar Pump is a small, single-channel electronic infusion device used in homes, hospitals, and other settings for administering medical fluids.
The recall is due to a defect where the proximal and distal pressure sensor calibration can drift. This drift may cause the pump to fail the Proximal or Distal Occlusion Operational Test or report specific errors during setup or infusion, such as 'Cassette Check - D,' 'Proximal Occlusion,' or 'Pressure Calibration Error.'
In some cases, a pump with this issue may not detect actual occlusions or may issue false occlusion alarms. False alarms will stop the infusion and trigger visual and audible warnings to the user. Users should check their device serial numbers against the recall list and contact Hospira for instructions on corrective action.
The recalled product
- 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
- Manufacturer
- Hospira Inc.
- Category
- Medical Device — Infusion Pump
- Affected units
- 43,840
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- *** 1) List Number: 13086
- Serial Numbers: 15651117
- 15651119
- 15651121
- 15651122
- 15651124
- 15651125
- 15651128
- 15651129
- 15651131
- 15651134
- 15651138
- 15651140
- 15651123
- 15651132
- 15651133
- 15651136
- 15651137
- 15651139
- 15651116
Distribution
Part of a larger recall action
This product is one of 2 recalled by Hospira Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
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