CLASS II ONGOING Device recall · Reported 6 Apr 2022 · FDA Enforcement Report

Nimbus PainPro Ambulatory Infusion Pumps recalled by InfuTronix

InfuTronix is recalling Nimbus PainPro Ambulatory Infusion Pumps, distributed nationwide in the US. The recall was initiated on 19 Oct 2021 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codes(UDI): (01)00817170020086; Lot: 2009231440; Serial Numbers: 807483, 807484, 807485, 807486, 807487, 807489, 807490, 807491, 807492, 807493, 807494, 807495, 807496, 807497, 807498, 807499, 807500, 807502, 807651, 807652, 807653, 807507, 807508, 807509, 807510, 807511, 807512, 807513, 807514, 807515, 807516, 807517, 807518, 807519, 807520, 807521, 807522, 807523, 807524, 807525, 807526, 807527, 807528, 807529, 807530, 807531, 807532, 807533, 807534, 807535, 807536, 807537, 807538, 807539, 807540, 807541, 807542, 807543, 807544, 807545, 807546, 807547, 807548, 807549, 807550, 807551, 807552, 807553, 807554, 807654, 807655, 807656, 807657, 807658

Quantity recalled74 units

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-0832-2022
FDA event ID: 89711
Recalling firm: InfuTronix, Natick, MA
Classification: Class II
Status: Ongoing
Recall initiated: 19 Oct 2021
FDA classified: 29 Mar 2022
Reported: 6 Apr 2022
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Infusion Pumps

Timeline

19 Oct 2021	Recall initiated by company
29 Mar 2022	Classified by FDA	+161 days
6 Apr 2022	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

An unreleased Version 4 Protocol Library was installed on Nimbus PainPro (H) infusion pumps in error that may impact patient safety if used on patients.

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

Nimbus PainPro Ambulatory Infusion Pumps with software version v4, Model Number IT1072, sold as kit IT1075-DUKE-HSP, IT1076-DUKE-HSP and IT1077-DUKE-HSP

Where it was distributed

US Nationwide distribution in the states of NC and OH.

Nationwide North Carolina Ohio

Questions about this recall

Why was it recalled?

An unreleased Version 4 Protocol Library was installed on Nimbus PainPro (H) infusion pumps in error that may impact patient safety if used on patients.

Which lots are affected?

(UDI): (01)00817170020086; Lot: 2009231440; Serial Numbers: 807483, 807484, 807485, 807486, 807487, 807489, 807490, 807491, 807492, 807493, 807494, 807495, 807496, 807497, 807498, 807499, 807500, 807502, 807651, 807652, 807653, 807507, 807508, 807509, 807510, 807511, 807512, 807513, 807514, 807515, 807516, 807517, 807518, 807519, 807520, 807521, 807522, 807523, 807524, 807525, 807526, 807527, 807528, 807529, 807530, 807531, 807532, 807533, 807534, 807535, 807536, 807537, 807538, 807539, 807540, 807541, 807542, 807543, 807544, 807545, 807546, 807547, 807548, 807549, 807550, 807551, 807552, 807553, 807554, 807654, 807655, 807656, 807657, 807658

Where was it sold?

US Nationwide distribution in the states of NC and OH.

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 InfuTronix

All 4

Reported	Class	Recall	Company	Reason	Where
3 Apr 2024Device	CLASS I	Nimbus II Infusion System recalled by InfuTronix	InfuTronix	Packaging Defects	Nationwide
3 Apr 2024Device	CLASS I	Nimbus Administration Set recalled by InfuTronix	InfuTronix	Packaging Defects	Nationwide
31 Jul 2019Device	CLASS II	Nimbus Administration Set recalled by InfuTronix	InfuTronix	Packaging Defects	MA

Other Infusion Pumps recalls

All 546

Reported	Class	Recall	Company	Reason	Where
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
19 Aug 2026Device	CLASS I	Baxter Duo-Vent Solution Set and Male Luer Lock Adapter recalled	Baxter Healthcare	Other	Nationwide
22 Jul 2026Device	CLASS II	Plum Solo Precision IV Pump, v1.0.3 recalled by ICU Medical	ICU Medical	Other	Nationwide
1 Jul 2026Device	CLASS II	Intera Oncology Intera 3000 Hepatic Artery Infusion Pump recalled	Boston Scientific	Packaging Defects	Nationwide