Hospira GemStar Infusion Pump Recall for Potential Over-Infusion Risk
Hospira is recalling GemStar infusion pumps because the motor may rotate backwards during low-rate infusions, potentially causing over-infusion of medication.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a mechanical defect leading to over-infusion of medication, which poses a significant risk of injury to patients, meeting the criteria for a Severe rating.
Plain-English summary
Hospira Inc. is recalling specific GemStar infusion pumps due to a defect in the motor assembly. The GemStar Pump is a small, single-channel electronic infusion device designed for use in homes, hospitals, or other settings requiring electronic infusion. It can be powered by AC mains, rechargeable batteries, a docking station, or disposable AA batteries.
The recall is issued because, during infusions set at 2.0 mL/hr, the motor assembly may rotate backwards. This malfunction can result in the pump capturing additional medication, leading to over-infusion. The affected units are identified by List Numbers 13000, 13100, and 13150.
The recall covers pumps distributed worldwide, including the United States and numerous international markets. Users of these devices should stop using the affected pumps and contact Hospira Inc. for further instructions on replacement or repair.
The recalled product
- 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 disposab
- Manufacturer
- Hospira Inc.
- Category
- Medical Device — Infusion Pump
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- List Numbers: 13000
- 13100
- 13150
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Hospira Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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