BEUDAMED
    FDA Enforcement Class II Ongoing

    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 · Reported August 25, 2021

    Enforcement

    Recall Number
    Z-2297-2021
    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 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

    Code Info

    a) REF 3814773, Lot 11T00118 b) REF 3835773, Lot 11T00119 c) REF 3825773, Lot 11T00120 d) REF 3837773, Lot 11T00121 e) REF 3846773, Lot 11T00122 f) REF 3831473, Lot 11T00142 g) REF 3842473, Lot 11T00143 h) REF 3821473, Lot 11T00146 i) REF 3832473, Lot 11T00147 j) REF 3833473, Lot 11T00148 k) REF 3821573, Lot 11T00177 l) REF 3831573, Lot 11T00178 m) REF 3833573, Lot 11T00179 n) REF 3824773, Lot 11T00230 o) REF 3804773, Lot 11T00231 p) REF 3845773, Lot 11T00232 q) REF 3811473, Lot 11T05089 r) REF 3836773, Lot 11T05136 s) REF 3843473, Lot 11T05166 t) REF 3800473, Lot 11T10007 v) REF 3842573, Lot 12T00180 w) REF 3832573, Lot 11T10015 x) REF 3847773, Lot 11T10016 y) REF 3800573, Lot T1010018

    Distribution

    US Nationwide distribution in the states of FL and MN.

    Quantity

    229,320 units