Skip to content
Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 94124

2 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
February 21, 2024
Product types
Device
Classifications
Class I
Statuses
Ongoing
Recalling firm wording
InfuTronix LLC

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

2 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 2

Nimbus Administration Set; Nimbus Flex; Nimbus PainPro (a.k.a. Halo Ambulatory Infusion System); Catalog Number IT1025. Ambulatory Infusion Pump and components

Z-1285-2024
Recall number
Z-1285-2024
Initiated
February 21, 2024
Classification
Class I
Status
Ongoing
Recalling firm
InfuTronix LLC
Quantity
52,328 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

Code information

UDI-DI 00817170020000 Lots A100-150205200 A100-150415015 A100-150430270 A100-150611300 A100-150716620 A100D-1705191000 AZ060-171201564 AZ060-1801021020 AZ060-180609264 AZ060-180626552 AZ060-190104792 AZ060-1902151200 A100F-160707073 A100F-160908250 A100F-161114700 All units recalled

Distribution pattern

Domestic US distribution nationwide. No international distribution.

device · product 2 of 2

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

Z-1286-2024
Recall number
Z-1286-2024
Initiated
February 21, 2024
Classification
Class I
Status
Ongoing
Recalling firm
InfuTronix LLC
Quantity
52,328 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

Code information

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.

Distribution pattern

Domestic US distribution nationwide. No international distribution.