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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device

Hospira Inc.: During infusions of 2.0 mL/hr the motor assembly may rotate backwards capturing additional medication resulting in over-infusion.

Agency Publication Date: April 15, 2013
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Affected Products

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.

List Numbers: 13000, 13100, 13150

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.

List Numbers: 13086, 13087, 13088

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 64841
Status: Resolved
Manufacturer: Hospira Inc.
Manufactured In: United States
Units Affected: 2 products (1) List Number 13000: 25,119 pumps; 2) List Number 13100: 185 pumps; 3) List Number 13150: 13,497 pumps; 1) List Number 13086: 286 pumps; 3) List Number 13087: 45,376 pumps; 4) List Number 13088: 23,492 pumps)

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.