Z-1285-2024Class I

Nimbus Administration Set; Nimbus Flex; Nimbus PainPro (a.k.a. Halo Ambulatory Infusion System); Catalog...

Name: Z-1285-2024 Nimbus Administration Set; Nimbus Flex; Nimbus PainPro (a.k.a. Halo Ambulatory Infusion System); Catalog...
Creator: InfuTronix LLC
Published: 2024-02-21
License: https://open.fda.gov/license/

InfuTronix LLC / initiated 2024-02-21 / Open, Classified / root cause: design

FDA source

InfuTronix LLC began a recall of Nimbus Administration Set; Nimbus Flex; Nimbus PainPro (a.k.a. Halo Ambulatory Infusion System); Catalog Number IT1025. Ambulatory Infusion Pump and components on 2024-02-21. FDA classified it as Class I and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-1285-2024
Classification: Class I
Status: Open, Classified
Initiated: 2024-02-21
Posted: 2024-03-28
Recalling firm: InfuTronix LLC
Product: Nimbus Administration Set; Nimbus Flex; Nimbus PainPro (a.k.a. Halo Ambulatory Infusion System); Catalog Number IT1025. Ambulatory Infusion Pump and components
Product code: FRN Pump, Infusion
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.
Root cause tag: design
FDA root cause: Device Design
Action: On February 21, 2024, the firm began notifying customers via URGENT MEDICAL DEVICE REMOVAL letters. Customers were informed that the identified Nimbus Infusion Pumps are being removed from the market. The products will no longer be supported by InfuTronix for the Nimbus Infusion Pumps or related infusion sets beyond June 20, 2024. Customers of InfuTronix who have Nimbus Infusion Pumps and associated infusion sets in their possession should contact InfuTronix customer service at [email protected], where they will be instructed on the Return Material Authorization (RMA) process to be followed for returning the both the Nimbus Infusion Pumps and associated infusion sets. As the device will not be available or supported after June 20, 2024, InfuTronix encourages the healthcare provider to seek alternative methods of drug product infusion appropriate for their patient s needs, based on their medical expertise, at the earliest possible opportunity. ***Updated 4/12/24*** The firm issued updated letters on 4/9/24 to reflect that the recall had been classified Class I by the FDA. Effective immediately, Nimbus Pumps will no longer be shipped. However, administration sets will continue to be shipped through June 20, 2024.
Quantity in commerce: 52,328 total
Distribution: Domestic US distribution nationwide. No international distribution.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1285-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1285-2024	Class I	Ongoing	Voluntary: Firm initiated	2024-04-03	2024-03-28
Z-1286-2024	Class I	Ongoing	Voluntary: Firm initiated	2024-04-03	2024-03-28

Product code FRN

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)