Hospira Recalls GemStar Infusion Pumps Due to Unexpected Shutdowns
Hospira Inc. is recalling GemStar infusion pumps because they may shut off during use without warning, potentially interrupting patient medication delivery.
What this means for you
Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The agency classification is FDA Class I, which mandates a severity score of 5 according to the rubric.
Plain-English summary
Hospira Inc. is recalling GemStar infusion pumps, which are small, single-channel electronic infusion devices used in homes, hospitals, and other settings. The recall is being conducted because the pumps may shut off during use without warning.
The affected units are identified by List Numbers 13086, 13087, and 13088. The recall covers 286 pumps from List Number 13086, 45,376 pumps from List Number 13087, and 23,942 pumps from List Number 13088. 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 how to proceed. The agency has classified this recall as Class I, indicating a reasonable probability that use of the product could 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 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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