Severity
Moderate
FDA Devices recall · Reported September 21, 2016
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 …
Hospira Inc., A Pfizer Company recalled Hospira MedNet Medication Management Suite software, version 6.1, List Numbers 16037-64-0… - a moderate-severity action.
Hospira MedNet Medication Management Suite software, version 6.1, List Numbers 16037-64-0… was recalled by Hospira Inc., A Pfizer Company in September 21, 2016. Reason: Hospira MedNet 6.1 software, in combination with the SapphirePlus 13.1x infusion pump, may result in incorrec…. Check the official notice for the remedy. Verify recall #Z-2790-2016 with the FDA Devices before acting.
The recall
Hospira Inc., A Pfizer Company issued this moderate-severity FDA Devices recall-Hospira MedNet 6.1 software, in combination with the SapphirePlus 13.1x infusion pump, may result in incorrec….
Sourced from official FDA Devices enforcement records. Verify recall #Z-2790-2016 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
This FDA Devices action (record #Z-2790-2016) was formally reported on September 21, 2016, with the manufacturer initiating the action on July 28, 2016. It is classified under Moderate severity (Class II), with a current status of Terminated. Hospira Inc., A Pfizer Company is listed as the recalling firm, operating out of Lake Forest, IL. Federal records list the affected scope as 20.
The documented reason for this recall is: 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 data in the federal record shows the product reached: Worldwide Distribution - US including ND, TX, MI, MN, WI, IA, ME, HI, PA, MA, NJ, NY, CT, and Internationally to Canada.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Severity
Moderate
Affected scope
20
Related Recalls
6
3 from same agency
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.
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.
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-2790-2016 |
| Date reported | September 21, 2016 |
| Date initiated | July 28, 2016 |
| Recalling firm | Hospira Inc., A Pfizer Company |
| Firm location | Lake Forest, IL |
| Affected scope | 20 |
| Distribution | Worldwide Distribution - US including ND, TX, MI, MN, WI, IA, ME, HI, PA, MA, NJ, NY, CT, and Internationally to Canada. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported September 21, 2016. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.