FDA Device recall Z-1286-2024
Nimbus II Infusion System
- FDA Device
- Class I
- ongoing
- Published 2024-04-03
On 2024-04-03 the FDA classified a Class I recall of Nimbus II Infusion System by Infutronix, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1286-2024 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2024-02-21 |
| Published | 2024-04-03 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Infutronix |
| Distribution | US |
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.
Identifiers
| code_info | UDI-DI: Nimbus II PainPRO: UDI-DI 00817170020086, Lots AHZ081-190619096 AHZ081-200229480 AHZ081-2004171062 AHZ081-200…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 AGZ049-21 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1286-2024%22
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