Recall archive / FDA device enforcement
Nimbus II Infusion System; Nimbus II PainPRO IT1053; Nimbus II Flex IT1062; Nimbus II Plus IT1078; Nimbus II EpiD IT1... — FDA record Z-1286-2024
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 Feb 21, 2024. 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 II Infusion System; Nimbus II PainPRO IT1053; Nimbus II Flex IT1062; Nimbus II Plus IT1078; Nimbus II EpiD IT1124; Nimbus II EMS IT1063; Ambulatory Infusion Pump and components
- Reason
- InfuTronix is removing the Nimbus Infusion Pump Systems from the market due to multiple potential failure modes, including battery failure, upstream occlusion, system errors, drug product leakage, high or low flow rate, or damaged pump housing. The device will not be available or supported after June 20, 2024.
- Classification
- Class I
- Recalling firm
- InfuTronix LLC
- Quantity
- 52,328 total
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1286-2024
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-DI: Nimbus II PainPRO: UDI-DI 00817170020086, Lots AHZ081-190619096 AHZ081-200229480 AHZ081-2004171062 AHZ081-200517528 AHZ081-200714696 AHZ081-2009231440 AHZ081-201105480 AHZ081-201105360 AHZ081-201208288 AHZ081-2012081944 AHZ081-2012081944 AHZ081-2108141920 AHZ081-211123360 AHZ081-2111242568 AHZ081-22062072 A100G-170420044 A100G-170512429 AGZ049-170512429 AGZ049-170615116 AGZ049-170816391 AGZ049-170829480 AGZ049-1709071188 AGZ049-171027828 AGZ049-1712011824 AGZ049-171229744 AGZ049-1806091272 AGZ049-180626984 AGZ049-1809201152 AGZ049-1810241536 AGZ049-181102108 AGZ049-190104504 AGZ049-190104648 AGZ049-190314768 AGZ049-1903151440 AGZ049-190515480 AGZ049-190515960 AGZ049-1906271440 AGZ049-1907231776 AGZ049-190723360 AGZ049-190806144 AGZ049-190924504 AGZ049-191023480 AGZ049-1912161920 AGZ049-200102576 AGZ049-2002251632 AGZ049-200714960 AGZ049-200828960 AGZ049-2009241440 AGZ049-2011301920 AGZ049-2103231200 AGZ049-210324360 AGZ049-210422528 AGZ049-210809480 AGZ049-211121360 AGZ049-2111222136 AGZ049-2202064320 AGZ049-220207720 AGZ049-220629624 AGZ049-2208091920 AGZ049-2312141632 AGZ049-2312271440 AGZ049-2401081344; Nimbus II Flex: UDI-DI 00817170020093 Lots AGZ050-170621081 AGZ050-170622027 AGZ050-170623297 AGZ050-170829240 AGZ050-171027180 AGZ050-180402360 AGZ050-180517720 AGZ050-190527480 AGZ050-190813360 AGZ050-190910360 AGZ050-190924720 AGZ050-200114300 AGZ050-210219600; Nimbus II Plus: UDI-DI 00817170020161 Lots AJZ074-190215120 AJZ074-190513120 AJZ074-190722360 AJZ074-20010379 AJZ074-200417282 AJZ074-200604960 AJZ074-200903960 AJZ074-210219720 AJZ074-210303180 AJZ074-210325960 AJZ074-2111081200 AJZ074-2202072880 AJZ074-2206012640 AJZ074-2206213120 AJZ074-2208092040 AJZ074-2208092640; Nimbus II EpiD: UDI-DI 00817170020376 Lot ALZ103-200824420; Nimbus II EMS: UDI-DI 00817170020109 Lots AGZ057-170925120 AGZ057-171027300; HS-001 Nimbus Administration Set: 00817170020017 HS-002 Nimbus Administration Set: 00817170020048 HS-003 Nimbus Administration Set: 00817170020024 HS-004 Nimbus Administration Set: 00817170020031 HS-008 Nimbus Administration Set: 00817170020123 All units are recalled. |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Domestic US distribution nationwide. No international distribution.
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 3, 2024
- Recall initiation date
- Feb 21, 2024
- Center classification date
- Mar 28, 2024
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.