FDA Device recall Z-0350-2014
The GemStar Pump is a small and lightweight, single channel infusion device designed for use in the home, in the hospital, or anywhere elec…
- FDA Device
- Class I
- terminated
- Published 2013-11-27
On 2013-11-27 the FDA classified a Class I recall of The GemStar Pump is a small and lightweight, single channel infusion device designed for use in the home, in the hospital, or anywhere elec… by Hospira, citing 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 Technica….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0350-2014 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2013-03-15 |
| Published | 2013-11-27 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Hospira |
| Distribution | AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY |
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 disposable AA alkaline batteries. When powered by batteries, The GemStar Pump is ideal for ambulatory patients.
Reason
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, not detected occlusions or issue false occlusion alarms, which will stop the infusion and invoke visual and audible warnings to the user.
Identifiers
| code_info | *** 1) List Number: 13086, Serial Numbers: 15651117 , 15651119 , 15651121, 15651122 , 15651124 , 15651125 ,…*** 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 , 15651118 , 15651120 , 15651126 , 15651127 , 15651130 , 15651135 , 15651141 , 15651142 , 15651143 , 15651144 , 15651147 , 15651148 , 15651151 , 15651152 , 15651153 , 15651154 , 15651156 , 15651157 , 15651158 , 15651159 , 15651160 , 15651161 , 15651162 , 15651163 , 15651164 , 15651165 , 15651145 , 15651155 , 15651149 , 18877402 , 18877406 , 18877407 , 18877412 , 18877415 , 18877417 , 18877424 , 18877429 , 18877430 , 18877436 , 18877440 , 18877443 , 18877401 , 18877403 , 18877404 , 18877405 , 18877408 , 18877409 , 18877410 , 18877411 , 18877413 , 18877414 , 18877416 , 18877418 , 18877419 , 18877420 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0350-2014%22
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