Z-2790-2016Class II

Hospira MedNet Medication Management Suite software, version 6.1, List Numbers 16037-64-02 and 16037-64-03...

Name: Z-2790-2016 Hospira MedNet Medication Management Suite software, version 6.1, List Numbers 16037-64-02 and 16037-64-03...
Creator: Hospira Inc., A Pfizer Company
Published: 2016-07-28
License: https://open.fda.gov/license/

Abbott Medical / initiated 2016-07-28 / Terminated / root cause: software

FDA source

Hospira Inc., A Pfizer Company began a recall of 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... on 2016-07-28. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-2790-2016
Classification: Class II
Status: Terminated
Initiated: 2016-07-28
Posted: 2016-09-13
Terminated: 2018-11-02
Recalling firm: Abbott Medical
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.
Product code: FRN Pump, Infusion
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.
Root cause tag: software
FDA root cause: Software design
Action: Hospira sent an Urgent Medical Device Correction letter dated July 28, 2016, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. The letter provided instructions for step-by-step process to mitigate the issue. Customers with questions were instructed to contact Hospira Global Complaint Management at 1-800-441-4100 or Hospira Technical Service Center at 1-800-241-4002, option 4.
Quantity in commerce: 20
Distribution: Worldwide Distribution - US including ND, TX, MI, MN, WI, IA, ME, HI, PA, MA, NJ, NY, CT, and Internationally to Canada.
Product codes and lots: List Numbers 16037-64-02 and 16037-64-03

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2790-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2790-2016	Class II	Terminated	Voluntary: Firm initiated	2016-09-21	2016-09-13

Product code FRN

K141102Class IIHospira Mednet Medication Management SuiteHospira, Inc. / cleared 2014-07-08

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)