Hospira MedNet Software Recall for Dosing Unit Transmission Defect
Hospira is recalling 13 units of MedNet MMS software due to a defect that may fail to send specific dosing units to infusion pumps.
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 3/5 (High).
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 software defect that could lead to dosing unit mismatches, representing a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Hospira Inc. is recalling 13 units of the Hospira MedNet Medication Management Suite (MMS) software, specifically versions 5.5, 5.8.1, and 5.8.2. The recall is due to a software defect where the dosing units "nanog/kg/min" and "milliUnits/min" are not sent to a Plum A+ device (versions 13.40, 13.41, and 13.4.2) via Auto Programming when those dosing units are not properly established in the customized drug library.
The affected software is intended to facilitate networked communication between compatible computer systems and Hospira infusion pumps, allowing healthcare professionals to automate the programming of infusion parameters. The defect may result in a dosing unit mismatch on an unmatched medication.
The affected units were distributed in the United States in the states of Florida, Louisiana, Pennsylvania, Washington, and Wyoming, as well as in Hong Kong. Healthcare facilities should contact Hospira for further instructions on resolving the software defect.
The recalled product
- Product
- The Hospira MedNet Medication Management Suite (MMS). Product Usage: The Hospira MedNet Medication Management Suite (MMS) is intended to facilitate networked communication between MMS compatible computer systems and Hospira infusion pumps. The MMS provides trained healthcare…
- Manufacturer
- Hospira Inc.
- Category
- Medical Device — Software
- Affected units
- 13
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 (6)
- 1) Software Version 5.5
- List Number: 16037-04-13
- 2) Software Version 5.8.1
- List Number: 16037-04-31
- 3) Software Version 5.8.2
- List Number: 16037-04-33
Distribution
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