The Recall Desk
SevereFDA (Devices)·Z-2790-2016·Announced 2016-09-21

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.

What this means for you

Illness, injury, or structural failure has been reported. 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 co
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

Distributed in 13 states: