InfuTronix LLC: 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

Is my product affected?

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

• UPC 00817170020086

Check against the official notice below — it lists the full affected range.

What happened

InfuTronix LLC is recalling 74 Nimbus PainPro ambulatory infusion pumps with software version v4 (Model Number IT1072, sold as kits IT1075-DUKE-HSP, IT1076-DUKE-HSP, and IT1077-DUKE-HSP) distributed nationwide in North Carolina and Ohio. An unreleased Version 4 Protocol Library was installed on these pumps in error, which may impact patient safety if the devices are used on patients.

The recall affects pumps with Lot 2009231440 and specific serial numbers ranging from 807483 to 807658. The source document does not specify a remedy or recommended action for affected consumers.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

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.

Details from the source

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. Distribution: US Nationwide distribution in the states of NC and OH. Quantity: 74 units Lot/code info: (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

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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