BEUDAMED
    FDA Recall Open, Classified

    DELTAVEN Y DNL Safety I.V. Catheter in Pur with closed system: a) REF 3832572 b) REF 3842572 c) REF 3821572 d) REF 3833572 e) REF 3831572 f) REF 3810572 g) REF 3852572

    Recall: Z-2296-2021 · Initiated June 21, 2021

    Recall

    Recall Number
    Z-2296-2021
    Event Number
    88234
    Firm
    Delta Med SpA Via Guido Rossa 20 Viadana Italy
    FEI Number
    3006846316
    Product Code
    FOZ
    Status
    Open, Classified
    Root Cause
    Process control
    Initiated
    June 21, 2021

    Description

    DELTAVEN Y DNL Safety I.V. Catheter in Pur with closed system: a) REF 3832572 b) REF 3842572 c) REF 3821572 d) REF 3833572 e) REF 3831572 f) REF 3810572 g) REF 3852572

    Reason

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

    Action

    The firm disseminated the notices on 06/21/2021 by email. The firm is requesting destruction of the affected devices at the consignee.

    Distribution

    US Nationwide distribution in the states of FL and MN.

    Quantity

    203,680 units