The GemStar Pump is a small and lightweight — Class I medical device recall Z-0349-2014
Terminated recall by Hospira Inc., reported 2013-11-27, distributed in AK, AL, AR, AZ, CA, CO, CT, DC…. The proximal and distal pressure sensor calibration can drift resulting in the pump failing the Proximal or Di
| Recall number | Z-0349-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Hospira Inc., Lake Forest, IL, United States |
| Recall initiated | 2013-03-15 |
| Classified | 2013-11-21 |
| Reported by FDA | 2013-11-27 |
| Terminated | 2017-03-07 |
| Distributed | 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 |
| Countries outside the US | AE, AT, AU, BE, BH, BR, CA, CH, CL, CN, CO, DE, DK, EG, ES, FI, FR, GB, GR, HK, HR, HU, IE, IL, IS, IT, JO, JP, KR, KW, LB, LU, MT, MY, NL, NO, NZ, OM, PH, PT, QA, RO, SA, SE, SI, TH, TR, TW, ZA |
| Reason classes | device malfunction |
| Serial numbers | 12470257, 12470279, 12470294, 12470317, 12470350, 12470351, 12470354, 12470375, 12470380, 12470387, 12470399, 12470403, 12470447, 12470457, 12470465, 12470492, 12470501, 12470506, 12470517, 12470520, 12470550, 12470573, 12470576, 12470578, 12470581 and 475 more |
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 for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0349-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.