The Recall Desk
HighFDA (Devices)·Z-2027-2014·Announced 2014-07-16

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.

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 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
Hazard
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

Distributed nationwide across the United States.

The notice also names 5 states specifically:

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