BEUDAMED
    FDA Enforcement Class I Ongoing

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

    Recall: Z-1285-2024 · Reported April 3, 2024

    Enforcement

    Recall Number
    Z-1285-2024
    Event ID
    94124
    Classification
    Class I
    Status
    Ongoing
    Product Type
    Devices
    Firm
    InfuTronix LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 3, 2024
    Initiation Date
    February 21, 2024
    Classification Date
    March 28, 2024
    Address
    177 Pine St, N/A, Natick, MA, 01760-1331, United States

    Description

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

    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.

    Code Info

    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

    Domestic US distribution nationwide. No international distribution.

    Quantity

    52,328 total