Recall archive / FDA device enforcement
Nimbus PainPro Ambulatory Infusion Pumps with software version v4, Model Number IT1072, sold as kit IT1075-DUKE-HSP, ... — FDA record Z-0832-2022
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Oct 19, 2021. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- 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
- 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.
- Classification
- Class II
- Recalling firm
- InfuTronix LLC
- Quantity
- 74 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0832-2022
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | (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 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
US Nationwide distribution in the states of NC and OH.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- Apr 6, 2022
- Recall initiation date
- Oct 19, 2021
- Center classification date
- Mar 29, 2022
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.