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Recall Observatory FDA recall evidence

Device 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 computer systems and Hospital infusion pumps.

Z-2790-2016

July 28, 2016

Class II

Product summary

Firm
Hospira Inc., A Pfizer Company
Event
Event 74903
Status
Terminated
Classification
Class II
Quantity
20
Official record key
device-enforcement:Z-2790-2016

Official wording

Reason: Hospira MedNet 6.1 software, in combination with the SapphirePlus 13.1x infusion pump, may result in incorrect bolus amount calculations for drugs whose concentrations are listed in Million Units.

Code information: List Numbers 16037-64-02 and 16037-64-03

Distribution pattern: Worldwide Distribution - US including ND, TX, MI, MN, WI, IA, ME, HI, PA, MA, NJ, NY, CT, and Internationally to Canada.

Derived failure modes

  • Device software or design

    reason.device_software_design · v1.0.0

    software, in combination with the SapphirePlus 13.1x infusion pump, may result in