FDA recall Z-1285-2024

Product

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

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.

Key facts

Status

Ongoing

Initiation date

2024-02-21

Report date

2024-04-03

Voluntary/Mandated

Voluntary: Firm initiated

Location

Natick, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1285-2024