Z-0832-2022Class II

Nimbus PainPro Ambulatory Infusion Pumps with software version v4, Model Number IT1072, sold as kit...

Name: Z-0832-2022 Nimbus PainPro Ambulatory Infusion Pumps with software version v4, Model Number IT1072, sold as kit...
Creator: InfuTronix LLC
Published: 2021-10-19
License: https://open.fda.gov/license/

InfuTronix LLC / initiated 2021-10-19 / Open, Classified / root cause: manufacturing process

FDA source

InfuTronix LLC began a recall of 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 on 2021-10-19. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0832-2022
Classification: Class II
Status: Open, Classified
Initiated: 2021-10-19
Posted: 2022-03-29
Recalling firm: InfuTronix LLC
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
Product code: FRN Pump, Infusion
Reason for recall: 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.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: An IMPORTANT PRODUCT INFORMATION letter dated 10/19/21 was sent to customers. InfuTronix LLC has recently become aware of an unreleased Version 4 Protocol Library for Duke University Hospital was installed on your Nimbus PainPro (H) infusion pumps in error that may impact patient safety if used on patients. Please ensure that all your potential customers and potential users in your facility are made aware of this notification and the recommended actions. Product Issue Version 4 of the Duke Protocol Library was installed on your infusion pumps in error. Affected Product Details Nimbus PainPro (H) Pump, Model numbers: IT1072, sold as kits IT1075-DUKE-HSP Total number of infusion pumps affected: 3 Lot numbers involved: 2009231440 Instructions 1. Place all units you have in-house on product-hold and stop further distribution 2. Inform your customer to discontinue use of the affected infusion pumps. Product Correction InfuTronix will be contacting you to resolve this issue as quickly as possible. Contact Information Your Account Manager, Vann Griffin, email: [email protected], phone: (919) 606-8339 Or John LaFratta, Vice President of Sales, email: john.lafratta@ nimbuspainpro.com , phone: 315-729-5564. Please be assured that maintaining a high level of safety and quality is our highest priority. If you have any questions, please contact us immediately.
Quantity in commerce: 74 units
Distribution: US Nationwide distribution in the states of NC and OH.
Product codes and lots: (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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0832-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0832-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-04-06	2022-03-29

Product code FRN

K153193Class IIHalo II Ambulatory Infusion System (also with trade names Nimbus II Ambulatory Infusion System, EVAA Ambulatory Infusion System)Zyno Medical, LLC / cleared 2016-08-30

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)