Reported Nov 27, 2013 · Terminated
The GemStar Pump is a small and lightweight, single channel infusion device designed for use in the home, in the…
Hospira Inc.
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Hospira Inc. · 275 N Field Dr · Lake Forest, IL · 60045-2579
Is this the product you have?
- 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.
- Lot codes and dates
- *** 1)
- List Number13086
- Serial Numbers
174 of 174 codes
156511171565111915651121156511221565112415651125156511281565112915651131156511341565113815651140156511231565113215651133156511361565113715651139156511161565111815651120156511261565112715651130156511351565114115651142156511431565114415651147156511481565115115651152156511531565115415651156156511571565115815651159156511601565116115651162156511631565116415651165156511451565115515651149188774021887740618877407188774121887741518877417188774241887742918877430188774361887744018877443
- List Number13087
- Serial Numbers
2,329 of 2,329 codes
156610771566123615661349156613251566134715661440156613961566139115661404156614491566150775000147750001607500018875000163750002747500029775000207750003617500032315661660156616801566179815661779156617191566175715661689156617841566174815661915156617541566175915661722156617971566190515661976750501061566195275050123750501527505014475050390750502587505041015662002156621221566215515662182156621251566219615662219156622431566198915662170156623751566232215662377156624071566227015662595
- Amount recalled
- 43,840
This recall covers 5 products
The agency filed one notice per product. You are reading one of them; the other 4 are below.
Where it was sold
Why it was recalled
Stop using this product now
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.
Using this product could cause serious injury, illness or death — stop using it now.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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