Nimbus II Infusion System; Nimbus II PainPRO IT1053; Nimbus II Flex IT1062; Nimbus II Plus IT1078; Nimbus II EpiD I
Summary
The FDA issued a Class I for Nimbus II Infusion System; Nimbus II PainPRO IT1053; Nimbus II Flex IT1062; by InfuTronix LLC. Reason: InfuTronix is removing the Nimbus Infusion Pump Systems from the market due to multiple potential failure modes, including battery failure, upstream o.
Details
Source
Device Recall
External ID
Z-1286-2024
Action Date
2024-04-03
Status
Ongoing
Category
device
Product Description
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
Lot/Code Info: 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.
Quantity Affected: 52,328 total
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.
Distribution
Domestic US distribution nationwide. No international distribution.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-02-21
Company
Natick, MA
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 163 device recalls issued in the same week, part of 403 device-related FDA actions this month.
InfuTronix LLC has 3 FDA actions in our database, including 3 recalls.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (InfuTronix LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does InfuTronix LLC have FDA actions?
InfuTronix LLC has 3 FDA actions in our database, including 3 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1286-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
Want to know the moment something like this happens?
Get alerts for deviceRelated Actions
MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Straight Extensions, IC Tray REF: 888810200
Covidien LP · 2023-08-23
Sterile Procedural Trays, labeled as the following: a. BREAST AUGMENTATION b. BREAST REDUCTION CDS c. CUH ABDOMINO
MEDLINE INDUSTRIES, LP - Northfield · 2023-02-15
VTC Regular Kit Nephrostomy Catheter System Kit, Material Number REF M001245300; to provide external drainage of the uri
Boston Scientific Corporation · 2024-09-25
EnChroma Safety Glasses with Rx Indoor Universal Lenses: Martinez Cx1 Indoor Rx, SKU: Cx.PC.IN.MTZ.BK.Rx; Summit Indoo
Enchroma Inc · 2024-11-27
Otological Ventilation Tube - T-Tube 9mm - Silicone; Product Code: NZ3309;
Adept Medical Ltd · 2025-01-29