BEUDAMED
    FDA Recall Open, Classified

    DELTAVEN FASTFLASH, Safety I.V. Catheter in Pur with closed system: a) REF 3814773 b) REF 3835773 c) REF 3825773 d) REF 3837773 e) REF 3846773 f) REF 3831473 g) REF 3842473 h) REF 3821473 i) REF 3832473 j) REF 3833473 k) REF 3821573 l) REF 3831573 m) REF 3833573 n) REF 3824773 o) REF 3804773 p) REF 3845773 q) REF 3811473 r) REF 3836773 s) REF 3843473 t) REF 3800473 v) REF 3842573 w) REF 3832573 x) REF 3847773 y) REF 3800573

    Recall: Z-2297-2021 · Initiated June 21, 2021

    Recall

    Recall Number
    Z-2297-2021
    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 FASTFLASH, Safety I.V. Catheter in Pur with closed system: a) REF 3814773 b) REF 3835773 c) REF 3825773 d) REF 3837773 e) REF 3846773 f) REF 3831473 g) REF 3842473 h) REF 3821473 i) REF 3832473 j) REF 3833473 k) REF 3821573 l) REF 3831573 m) REF 3833573 n) REF 3824773 o) REF 3804773 p) REF 3845773 q) REF 3811473 r) REF 3836773 s) REF 3843473 t) REF 3800473 v) REF 3842573 w) REF 3832573 x) REF 3847773 y) REF 3800573

    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

    229,320 units