Hospira GemStar Infusion Pump Recall for Potential Over-Infusion
Hospira is recalling GemStar infusion pumps because the motor may rotate backwards during low-rate infusions, causing the device to deliver too much 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, and the hazard involves a significant injury risk (over-infusion of medication) without reported fatalities, meeting the criteria for a Severe rating.
Plain-English summary
Hospira Inc. is recalling GemStar infusion pumps, which are small, single-channel electronic devices used for administering medication in home, hospital, and ambulatory settings. The recall covers specific units identified by List Numbers 13086, 13087, and 13088.
The recall is being issued because, during infusions set at 2.0 mL/hr, the pump's motor assembly may rotate backwards. This malfunction can cause the pump to capture additional medication, resulting in an over-infusion of the drug being administered.
The affected pumps were distributed worldwide, including in the United States and numerous international markets. Users of these devices should contact Hospira Inc. for instructions on how to address the defect and ensure patient safety.
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: 13086
- 13087
- 13088
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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