Z-0832-2022 Class II Ongoing
FDA device recall Z-0832-2022 was initiated by InfuTronix LLC on Oct 19, 2021 and is designated Class II. 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. The recall status is ongoing. Affected quantity: 74 units.
Recall Details
- Product Type
- Devices
- Report Date
- Apr 6, 2022
- Initiation Date
- Oct 19, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 74 units
Product Description
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
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 Pattern
US Nationwide distribution in the states of NC and OH.
Code Information
(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
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0832-2022
- openFDA file date
- Nov 3, 2026
- Loaded by RegDataLab
- Nov 4, 2026