Home / Recalls / Hospira Inc., A Pfizer Company / Z-2790-2016

Z-2790-2016 Class II Terminated

Recalled by Hospira Inc., A Pfizer Company — Lake Forest, IL

FDA device recall Z-2790-2016 was initiated by Hospira Inc., A Pfizer Company on Jul 28, 2016 and is designated Class II. Reason for recall: 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. The recall status is terminated (terminated Nov 2, 2018). Affected quantity: 20.

Recall details

Product Type: Devices
Report Date: Sep 21, 2016
Initiation Date: Jul 28, 2016
Termination Date: Nov 2, 2018
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 20

Product description

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.

Reason for recall

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.

Distribution pattern

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

Code information

List Numbers 16037-64-02 and 16037-64-03

Source

Dataset: openFDA device recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for Z-2790-2016
openFDA file date: Nov 10, 2026
Loaded by RegDataLab: Nov 11, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.

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