Hospira GemStar Infusion Pumps Recalled for Unintended Shutdowns
Hospira Inc. is recalling GemStar infusion pumps because they may shut off during use without warning. The recall affects pumps distributed worldwide.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class I, which per the rubric mandates a score of at least 4 (Severe) due to the potential for serious adverse health consequences.
Plain-English summary
Hospira Inc. is recalling GemStar infusion pumps due to a defect where the device may shut off during use without warning. The GemStar Pump is a small, lightweight, single-channel infusion device designed for use in the home, hospital, or other settings requiring electronic infusion. It can be powered by an AC mains adaptor, rechargeable battery pack, docking station, or two disposable AA alkaline batteries.
The recall covers specific list numbers: 13000 (25,119 pumps), 13100 (185 pumps), and 13150 (13,497 pumps). These devices were distributed nationwide in the United States and internationally to numerous countries including Australia, Canada, and various nations in Europe, Asia, and the Middle East.
Consumers and healthcare providers should stop using the affected pumps and contact Hospira Inc. for instructions on replacement or repair. The recall is classified as Class I by the FDA, indicating a reasonable probability that the use of, or exposure to, the violative product will cause serious adverse health consequences or death.
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…
- 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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