The GemStar Pump is a small and lightweight, single channel infusion device designed for use in t...
FDA Device Recall #Z-0349-2014 — Class I — March 15, 2013
Recall Summary
| Recall Number | Z-0349-2014 |
| Classification | Class I — Serious risk |
| Date Initiated | March 15, 2013 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Hospira Inc. |
| Location | Lake Forest, IL |
| Product Type | Devices |
| Quantity | 1) List Number 13000: 2,162 pumps; 2) List Number 13100: 15 pumps; 3) List Number 13150: 1,955 pumps |
Product Description
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.
Distribution Pattern
Worldwide Distribution - USA including 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. Internationally to Australia, New Zealand, China, Hong Kong, Taiwan, Japan, Korea, Philippines, Thailand, Malaysia, Canada, Austria, Bahrain, Belgium, Croatia, Denmark, Egypt, Finland, France, Germany, Gibraltar, Greece, Hungary, Iceland, Ireland, Israel, Italy, Jordan, Kuwait, Lebanon, Libya, Luxembourg, Malta, Netherlands, Norway, Oman, Portugal, Qatar, Romania, Saudi Arabia, Slovenia, South Africa, Spain, Sweden, Switzerland, Turkey, UK, United Arab Emirates, Brazil, Chile and Colombia.
Lot / Code Information
*** 1) List Number 13000, Serial Numbers: 98121336 , 98121173 , 98120835 , 98120730 , 98120768 , 98120782 , 98120788 , 98120822 , 98120824 , 98120839 , 98120856 , 98120880 , 98120885 , 98120895 , 98120915 , 98120749 , 98120769 , 98120774 , 98120784 , 98120859 , 98120884 , 98121019 , 98121066 , 98121079 , 98121083 , 98121135 , 98121153 , 98121163 , 98121197 , 98120522 , 98120653 , 13431222 , 98120635 , 98120405 , 98120508 , 98120634 , 98121147 , 98120543 , 12470380 , 98120512 , 98120815 , 98120681 , 97971490 , 97970893 , 97970240 , 98070264 , 98070295 , 99170068 , 99170032 , 98070345 , 98070476 , 98070905 , 98070995 , 97972107 , 97972609 , 97971538 , 98021653 , 98021821 , 99400401 , 99400435 , 97970456 , 13431303 , 98021816 , 97972825 , 98021121 , 97971767 , 99107521 , 98020395 , 14180727 , 98120459 , 98120495 , 98120777 , 98020964 , 98070286 , 98121157 , 97972571 , 97970541 , 97971254 , 98120535 , 98120640 , 98120840 , 97970194 , 98021636 , 98020575 , 97972639 , 99222573 , 98021550 , 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13530228 , 13530338 , 13530203 , 13530205 , 13530328 , 13530312 , 13530387 , 13530209 , 13530312 , 12771348 , 13530386 , 13530385 , 13530331 , 13530373 , 13530370 ; *** 3) List Number 13150, Serial Numbers: 98431537 , 98430945 , 98431018 , 98431041 , 13637227 , 99271058 , 98431008 , 99270417 , 98930032 , 98930073 , 98930074 , 98930083 , 13631592 , 99749369 , 98430113 , 98430192 , 99450473 , 98410749 , 13630146 , 98431142 , 98431205 , 13630031 , 98930058 , 98431409 , 98410005 , 98410015 , 98411582 , 98410379 , 98411404 , 99450476 , 98410027 , 98410353 , 98410363 , 98411239 , 98431167 , 98410231 , 98410048 , 98410580 , 99270394 , 13631348 , 98431086 , 99749251 , 98410752 , 99450050 , 98410387 , 99749532 , 13631527 , 98410741 , 98410836 , 98930402 , 99749112 , 98430321 , 98411440 , 12720251 , 99450479 , 98431440 , 13636963 , 98431000 , 99270409 , 98431149 , 98411588 , 98410556 , 98410563 , 98410910 , 13630816 , 98431200 , 98410569 , 98411468 , 99450565 , 98432002 , 12720318 , 13630186 , 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Other Recalls from Hospira Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1832-2016 | Class II | The Plum 360 is a large volume infuser capable ... | Mar 25, 2016 |
| Z-1833-2016 | Class II | The Plum A+ is a dual-line volumetric infusion ... | Mar 25, 2016 |
| Z-0863-2016 | Class II | The Symbiq infusion pump is a device used in a ... | Dec 22, 2015 |
| Z-1074-2015 | Class I | The Plum A+ Infusion System is designed to meet... | Jul 2, 2014 |
| Z-1073-2015 | Class I | The Plum A+ Infusion System is designed to meet... | Jul 2, 2014 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.