CLASS II Device recall · Reported 21 Sep 2016 · FDA Enforcement Report

Hospira MedNet Medication Management Suite recalled

Hospira Inc. A Pfizer is recalling Hospira MedNet Medication Management Suite, distributed in 13 states. The recall was initiated on 28 Jul 2016 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesList Numbers 16037-64-02 and 16037-64-03

Quantity recalled20

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2790-2016
FDA event ID: 74903
Recalling firm: Hospira Inc. A Pfizer, Lake Forest, IL
Classification: Class II
Status: Terminated
Recall initiated: 28 Jul 2016
FDA classified: 13 Sep 2016
Reported: 21 Sep 2016
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Infusion Pumps

Timeline

28 Jul 2016	Recall initiated by company
13 Sep 2016	Classified by FDA	+47 days
21 Sep 2016	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

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.

Where it was distributed

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

Connecticut Hawaii Iowa Massachusetts Maine Michigan Minnesota North Dakota New Jersey New York Pennsylvania Texas Wisconsin

Questions about this recall

Why was it recalled?

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.

Which lots are affected?

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

Where was it sold?

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

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Hospira Inc. A Pfizer

All 9

Reported	Class	Recall	Company	Reason	Where
14 Mar 2018Drug	CLASS II	Labetalol Hydrochloride Injection, USP, 100 mg recalled	Hospira Inc. A Pfizer	Foreign Material	Nationwide
26 Jul 2017Drug	CLASS III	Argatroban Injection, 250 mg/ (100 mg/mL) Single-use vial recalled	Hospira Inc. A Pfizer	Potency & Assay	Nationwide
21 Jun 2017Drug	CLASS II	Levophed norepinephrine bitartrate, injection, USP, 4 mg / (1 mg/mL) recalledLevophed	Hospira Inc. A Pfizer	Packaging Defects	Nationwide
12 Apr 2017Drug	CLASS I	Vancomycin Hydrochloride for Injection, USP, Pharmacy recalled	Hospira Inc. A Pfizer	Particulate Matter	Nationwide
1 Mar 2017Drug	CLASS II	METRONIDazole Injection, USP 500 mg (5 mg/mL) recalled	Hospira Inc. A Pfizer	Sterility	Nationwide

Other Infusion Pumps recalls

All 549

Reported	Class	Recall	Company	Reason	Where
23 Sep 2026Device	CLASS I	BD Alaris Pump Infusion Sets 10561554* recalled by BD Switzerland Sarl	BD Switzerland Sarl	Other	Nationwide
23 Sep 2026Device	CLASS II	IV Non-Dedicated Gravity Administration Sets with drip chambers recalled	ICU Medical	Foreign Material	Nationwide
23 Sep 2026Device	CLASS II	Plum administration sets recalled by ICU Medical	ICU Medical	Particulate Matter	Nationwide
9 Sep 2026Device	CLASS II	Baxter Novum IQ Syringe Pump, Loaner recalled by Baxter Healthcare	Baxter Healthcare	Device Malfunction	Nationwide
9 Sep 2026Device	CLASS II	Baxter Novum IQ Syringe Pump recalled by Baxter Healthcare	Baxter Healthcare	Device Malfunction	Nationwide