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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 74903

1 recalled-product record grouped only because every row carries this exact official event ID.

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Event summary

Timeline bucket
July 28, 2016
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Hospira Inc., A Pfizer Company

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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
Recall number
Z-2790-2016
Initiated
July 28, 2016
Classification
Class II
Status
Terminated
Quantity
20

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
software, in combination with the SapphirePlus 13.1x infusion pump, may result in

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

Compare all device evidence states

Inspect official wording and provenance

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.

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.