InfuTronix LLC: Medical Device Recall in 2024 - (Recall #: Z-1285-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

Product Description:

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

Product Classification:

Class I

Date Initiated: February 21, 2024

Date Posted: April 3, 2024

Recall Number: Z-1285-2024

Event ID: 94124

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.

Status: Ongoing

Product Quantity: 52,328 total

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.

Voluntary or Mandated:

Voluntary: Firm initiated