FDA Medical Device Recalls (openFDA)
InfuTronix LLC: Nimbus Administration Set; Nimbus Flex; Nimbus PainPro (a.k.a. Halo Ambulatory Infusion System); Catalog Number IT1025. Ambulatory Infusion Pump and components
- Recall number
- Z-1285-2024
- 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
- Status
- Open, Classified
- Initiated
- 2024-02-21
- Posted
- 2024-03-28
- Terminated
- not on file
- 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.
- 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 Customerservice@intuvie.com, 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
- 52,328 total
- Distribution
- Domestic US distribution nationwide. No international distribution.
- Lot, serial or model codes
- 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
- 510(k) numbers
- K140783, K153193
- PMA numbers
- not on file
- Product code
- FRN
- Firm FEI
- 3011581906
- Firm city
- Natick
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28