BEUDAMED
    FDA Recall Open, Classified

    Nimbus PainPro Ambulatory Infusion Pumps with software version v4, Model Number IT1072, sold as kit IT1075-DUKE-HSP, IT1076-DUKE-HSP and IT1077-DUKE-HSP

    Recall: Z-0832-2022 · Initiated October 19, 2021

    Recall

    Recall Number
    Z-0832-2022
    Event Number
    89711
    Firm
    InfuTronix LLC
    FEI Number
    3011581906
    Product Code
    FRN
    Status
    Open, Classified
    Root Cause
    Employee error
    Initiated
    October 19, 2021
    Address
    177 Pine St, Natick, MA, 01760-1331

    Description

    Nimbus PainPro Ambulatory Infusion Pumps with software version v4, Model Number IT1072, sold as kit IT1075-DUKE-HSP, IT1076-DUKE-HSP and IT1077-DUKE-HSP

    Reason

    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.

    Action

    An IMPORTANT PRODUCT INFORMATION letter dated 10/19/21 was sent to customers. InfuTronix LLC has recently become aware of an unreleased Version 4 Protocol Library for Duke University Hospital was installed on your Nimbus PainPro (H) infusion pumps in error that may impact patient safety if used on patients. Please ensure that all your potential customers and potential users in your facility are made aware of this notification and the recommended actions. Product Issue Version 4 of the Duke Protocol Library was installed on your infusion pumps in error. Affected Product Details Nimbus PainPro (H) Pump, Model numbers: IT1072, sold as kits IT1075-DUKE-HSP Total number of infusion pumps affected: 3 Lot numbers involved: 2009231440 Instructions 1. Place all units you have in-house on product-hold and stop further distribution 2. Inform your customer to discontinue use of the affected infusion pumps. Product Correction InfuTronix will be contacting you to resolve this issue as quickly as possible. Contact Information Your Account Manager, Vann Griffin, email: [email protected], phone: (919) 606-8339 Or John LaFratta, Vice President of Sales, email: john.lafratta@ nimbuspainpro.com , phone: 315-729-5564. Please be assured that maintaining a high level of safety and quality is our highest priority. If you have any questions, please contact us immediately.

    Distribution

    US Nationwide distribution in the states of NC and OH.

    Quantity

    74 units