BEUDAMED
    FDA Recall Open, Classified

    Nimbus II Infusion System; Nimbus II PainPRO IT1053; Nimbus II Flex IT1062; Nimbus II Plus IT1078; Nimbus II EpiD IT1124; Nimbus II EMS IT1063; Ambulatory Infusion Pump and components

    Recall: Z-1286-2024 · Initiated February 21, 2024

    Recall

    Recall Number
    Z-1286-2024
    Event Number
    94124
    Firm
    InfuTronix LLC
    FEI Number
    3011581906
    Product Code
    FRN
    Status
    Open, Classified
    Root Cause
    Device Design
    Initiated
    February 21, 2024
    Posted
    March 28, 2024
    Address
    177 Pine St, Natick, MA, 01760-1331

    Description

    Nimbus II Infusion System; Nimbus II PainPRO IT1053; Nimbus II Flex IT1062; Nimbus II Plus IT1078; Nimbus II EpiD IT1124; Nimbus II EMS IT1063; 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.

    Action

    On February 21, 2024, the firm began notifying customers via URGENT MEDICAL DEVICE REMOVAL letters. Customers were informed that the identified Nimbus Infusion Pumps are being removed from the market. The products will no longer be supported by InfuTronix for the Nimbus Infusion Pumps or related infusion sets beyond June 20, 2024. Customers of InfuTronix who have Nimbus Infusion Pumps and associated infusion sets in their possession should contact InfuTronix customer service at [email protected], where they will be instructed on the Return Material Authorization (RMA) process to be followed for returning the both the Nimbus Infusion Pumps and associated infusion sets. As the device will not be available or supported after June 20, 2024, InfuTronix encourages the healthcare provider to seek alternative methods of drug product infusion appropriate for their patient s needs, based on their medical expertise, at the earliest possible opportunity. ***Updated 4/12/24*** The firm issued updated letters on 4/9/24 to reflect that the recall had been classified Class I by the FDA. Effective immediately, Nimbus Pumps will no longer be shipped. However, administration sets will continue to be shipped through June 20, 2024.

    Distribution

    Domestic US distribution nationwide. No international distribution.

    Quantity

    52,328 total