The Recall Desk
Agency classClass IOur severity:SevereFDA (Devices)·Z-0350-2014·Announced 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.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "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…"

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…
Manufacturer
Hospira Inc.
Category
Medical Device — Infusion Pump
Hazard
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

Distributed in 51 states:

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 →

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