BEUDAMED
    FDA Recall Open, Classified

    VariSoft Infusion Set, Single Use.

    Recall: Z-3186-2024 · Initiated July 23, 2024

    Recall

    Recall Number
    Z-3186-2024
    Event Number
    95224
    Firm
    Unomedical A/S Osted Aholmvej 1
    FEI Number
    1000477110
    Product Code
    FPA
    Status
    Open, Classified
    Root Cause
    Process change control
    Initiated
    July 23, 2024
    Posted
    September 19, 2024
    Address
    3 Lejre Denmark

    Description

    VariSoft Infusion Set, Single Use.

    Reason

    Specific VariSoftTM Infusion Sets were packaged using incorrect secondary packaging (boxes) branded "Trusteel Infusion Set".

    Action

    Unomedical initially notified the consignee on 07/23/2024 via meeting and followed up with a letter via email on 07/25/2024. The notification instructed the consignee to identify and quarantine any affected product in inventory, notify customers immediately, complete and return the response form and arrange for return of affected units.

    Distribution

    US Nationwide distribution in the state of California.