Hospira MedNet Software Recall for Incorrect Bolus Calculations
Hospira is recalling MedNet 6.1 software used with SapphirePlus infusion pumps because it may calculate incorrect bolus amounts for drugs in Million Units.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 II, which corresponds to a Severe severity score under the rubric. The defect involves incorrect medication dosing calculations, which poses a significant risk of harm.
Plain-English summary
Hospira Inc., A Pfizer Company, is recalling Hospira MedNet Medication Management Suite software, version 6.1, List Numbers 16037-64-02 and 16037-64-03. The recall involves 20 units of the software in combination with the SapphirePlus 13.1x infusion pump.
The recall was initiated because the software may result in incorrect bolus amount calculations for drugs whose concentrations are listed in Million Units. The Hospira MedNet Medication Management Suite is intended to facilitate networked communication between compatible computer systems and hospital infusion pumps.
The affected products were distributed worldwide, including in the United States (ND, TX, MI, MN, WI, IA, ME, HI, PA, MA, NJ, NY, CT) and internationally to Canada. Healthcare facilities should contact Hospira for instructions on how to address the software defect.
The recalled product
- Product
- Hospira MedNet Medication Management Suite software, version 6.1, List Numbers 16037-64-02 and 16037-64-03, in combination with the SapphirePlus 13.1x infusion pump Hospira MedNet Medication Management Suite is intended to facilitate networked communication between compatible…
- Manufacturer
- Hospira Inc., A Pfizer Company
- Affected units
- 20
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 (1)
- List Numbers 16037-64-02 and 16037-64-03
Distribution
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