Hospira Recalls GemStar Infusion Pumps Due to Unauthorized Dosage Reset Access
Hospira is recalling GemStar infusion pumps because patients are accessing dosage reset codes to change infusion rates set by doctors.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a high-risk medical device where unauthorized changes to infusion rates pose a risk of harm, but the source text does not report specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Hospira Inc. is recalling GemStar infusion pumps, including list numbers 13086, 13087, and 13088. The recall covers pumps used for intravenous, arterial, subcutaneous, and short-term epidural infusion of fluids, medications, and blood products.
The recall was initiated because some patients are obtaining access to dosage reset codes required to change the settings on these pumps. Patients are downloading the GemStar User/Service Manual from website sponsors, which allows them to alter the infusion rates originally set by their doctors.
The affected pumps were distributed worldwide, including in the United States and numerous countries in Europe, Asia, the Middle East, and Africa. Consumers and healthcare providers should verify if they possess these specific list numbers and consult their healthcare provider regarding the appropriate course of action.
The recalled product
- Product
- GemStar infusion pump, list numbers 13086 and 13087, GemStar infusion pump (pain management) list number 13088. Product Usage The pump is suitable for intravenous, arterial, subcutaneous, short-term epidural infusion and parenteral administration of general I.V. fluids, medi
- 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 (4)
- List Numbers: 13086
- 13087
- 13088
- Serial Numbers: All Serial Numbers
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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