Home / Recalls / Hospira Inc. / Z-2027-2014

Z-2027-2014 Class II Terminated

Recalled by Hospira Inc. — Lake Forest, IL

FDA device recall Z-2027-2014 was initiated by Hospira Inc. on Jun 6, 2014 and is designated Class II. Reason for recall: Hospira MedNet 5.5, 5.8.1, and 5.8.2 contains software defect where the dosing units of "nanog/kg/min" and "milliUnits/min" are not sent to a Plum A+ device (Version 13.40, 13.41, and 13.4.2) via Auto… The recall status is terminated (terminated Dec 6, 2016). Affected quantity: 13 units.

Recall Details

Product Type: Devices
Report Date: Jul 16, 2014
Initiation Date: Jun 6, 2014
Termination Date: Dec 6, 2016
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 13 units

Product Description

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 professionals with the capability to send, receive, report, and store information from interfaced external systems, and to configure and edit infusion programming parameters. The MMS is intended to provide a way to automate the programming of infusion parameters, thereby decreasing the amount of manual steps necessary to enter infusion data. All data entry and validation of infusion parameters is performed by a trained healthcare professional according to physicians orders.

Reason for Recall

Hospira MedNet 5.5, 5.8.1, and 5.8.2 contains software defect where the dosing units of "nanog/kg/min" and "milliUnits/min" are not sent to a Plum A+ device (Version 13.40, 13.41, and 13.4.2) via Auto Programming when those dosing units are not properly established in the customized drug library. A dosing unit mismatch of "nanog/kg/min" or "milliUnits/min" on an unmatched medication will produce a

Distribution Pattern

US Nationwide in the states of FL, LA, PA, WA, WY and the country of Hong Kong

Code Information

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

Source

Dataset: openFDA device recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for Z-2027-2014
openFDA file date: Oct 27, 2026
Loaded by RegDataLab: Oct 29, 2026

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

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