InfuTronix Recalls
4 recalls on record · July 31, 2019 to April 3, 2024 · Medical Devices
Recalls by year
19
22
24
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
April 3, 2024Medical DevicesFDA
InfuTronix LLC recalls Nimbus II Infusion System; Nimbus II PainPRO IT1053; Nimbus II Flex IT1062; Nimbus II Plus IT1078; Nimbus II EpiD I
Hazard: 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.
April 3, 2024Medical DevicesFDA
InfuTronix LLC recalls Nimbus Administration Set; Nimbus Flex; Nimbus PainPro (a.k.a. Halo Ambulatory Infusion System); Catalog Number IT10
Hazard: 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.
April 6, 2022Medical DevicesFDA
InfuTronix LLC recalls Nimbus PainPro Ambulatory Infusion Pumps with software version v4, Model Number IT1072, sold as kit IT1075-DUKE-HSP, IT1
Hazard: An unreleased Version 4 Protocol Library was installed on Nimbus PainPro (H) infusion pumps in error that may impact patient safety if used on patients.
July 31, 2019Medical DevicesFDA
InfuTronix LLC recalls Nimbus Administration Set, REF HS-004, UDI # 00817170020031 Product Usage: Administer fluids/medication from a conta
Hazard: Potential for tube leakage