Medical Device Recall: Nimbus Administration Set; Nimbus Flex; Nimbus PainPro (a.k.a. Halo Ambulatory Infusion System); Catalog Number IT1025. Ambulatory Infusion Pump and components
InfuTronix LLC · February 21, 2024
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.
States Affected
NATIONWIDE
Quantity Affected
52,328 total
Source: FDA (openFDA Device Enforcement)
Recall number: Z-1285-2024
Status: ongoing
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