BEUDAMED
    FDA Enforcement Class II Ongoing

    DELTAVEN Safety I.V. Catheter in Pur with closed system: a) REF 3836272 b) REF 3814272 c) REF 3845272 d) REF 3856272

    Recall: Z-2295-2021 · Reported August 25, 2021

    Enforcement

    Recall Number
    Z-2295-2021
    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

    DELTAVEN Safety I.V. Catheter in Pur with closed system: a) REF 3836272 b) REF 3814272 c) REF 3845272 d) REF 3856272

    Reason

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

    Code Info

    a) REF 3836272, Lot 11T80188 b) REF 3814272, Lot 11T80272 c) REF 3845272, Lot 12T80147 d) REF 3856272, Lot 12T80347

    Distribution

    US Nationwide distribution in the states of FL and MN.

    Quantity

    30,900 units