BEUDAMED
    FDA Enforcement Class II Ongoing

    NEO DELTA Self Safe 1, I.V. Catheter with PUR REF 3708122, Lot 00A1160627 5000 units

    Recall: Z-2300-2021 · Reported August 25, 2021

    Enforcement

    Recall Number
    Z-2300-2021
    Event ID
    88234
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Delta Med SpA
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 25, 2021
    Initiation Date
    June 21, 2021
    Classification Date
    August 16, 2021
    Address
    Via Guido Rossa 20, N/A, Viadana, N/A, N/A, Italy

    Description

    NEO DELTA Self Safe 1, I.V. Catheter with PUR REF 3708122, Lot 00A1160627 5000 units

    Reason

    Problems related to the sterilization of the medical devices; possible missing sterility of the medical device

    Code Info

    REF 3708122, Lot 00A1160627

    Distribution

    US Nationwide distribution in the states of FL and MN.

    Quantity

    5000 units