Hospira Recalls GemStar Infusion Pumps Due to Unauthorized Dosage Reset Access
Hospira Inc. is recalling GemStar infusion pumps because patients are using publicly available 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 medical device where unauthorized changes to infusion rates pose a risk of harm, but the source text does not report any 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 13000, 13100, and 13150, as well as the GemStar Infusion Pump for pain management. The recall covers all serial numbers of these devices. The pumps are used for intravenous, arterial, subcutaneous, and short-term epidural infusion of fluids, medications, and blood products.
The recall is being conducted because some patients have obtained access to dosage reset codes required to change the settings on the pumps. Patients are downloading the GemStar User/Service Manual from website sponsors to access these codes and are subsequently changing the infusion rates originally set by their doctors. The GemStar User/Service Manual should be removed from these websites.
The affected products were distributed worldwide, including nationwide in the United States and in numerous countries across Europe, the Middle East, Asia, and Africa. Consumers and healthcare providers should contact Hospira Inc. for further instructions regarding the recall and the removal of the manual from public websites.
The recalled product
- Product
- GemStar infusion pump, list numbers 13000 and 13100, GemStar Infusion Pump (pain management) list number 13150. 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: 13000
- 13100
- 13150
- 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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