BEUDAMED
    FDA Recall Open, Classified

    Medtronic Venous Cannulae: a) DLP 20 Fr. Malleable Single Stage Venous Cannula, Model Number 68120, b) DLP 24 Fr. Malleable Single Stage Venous Cannula, Model Number 68124, c) DLP 28 Fr. Malleable Single Stage Venous Cannula, Model Number 68128, d) DLP 30 Fr. Malleable Single Stage Venous Cannula, Model Number 68130, e) DLP 34 Fr. Malleable Single Stage Venous Cannula, Model Number 68134, f) DLP 12 Fr. Single Stage Venous Cannula, Model Number 67312, g) DLP 16 Fr. Single Stage Venous Cannula, Model Number 67316, h) DLP 16 Fr. Single Stage Venous Cannula, Model Number 67516, i) DLP 18 Fr. Single Stage Venous Cannula, Model Number 66118, j) DLP 18 Fr. Single Stage Venous Cannula, Model Number 67318, k) DLP 20 Fr. Single Stage Venous Cannula, Model Number 67320, l) DLP 20 Fr. Single Stage Venous Cannula, Model Number 69320, m) DLP 20 Fr. Single Stage Venous Cannula, Model Number 67520, n) DLP 22 Fr. Single Stage Venous Cannula, Model Number 66122, o) DLP 22 Fr. Single Stage Venous Cannula, Model Number 67522, p) DLP 24 Fr. Single Stage Venous Cannula, Model Number 67524, q) DLP 26 Fr. Single Stage Venous Cannula, Model Number 67526, r) DLP 28 Fr. Single Stage Venous Cannula, Model Number 66128, s) DLP 28 Fr. Single Stage Venous Cannula, Model Number 39628, t) DLP 28 Fr. Single Stage Venous Cannula, Model Number 67528, u) DLP 30 Fr. Single Stage Venous Cannula, Model Number 66130, v) DLP 31 Fr. Single Stage Venous Cannula, Model Number 69331, w) DLP 32 Fr. Single Stage Venous Cannula, Model Number 66132, x) DLP 34 Fr. Single Stage Venous Cannula, Model Number 67534, y) DLP 36 Fr. Single Stage Venous Cannula, Model Number 66236, z) MC2 28/36 Fr. Two Stage Venous Cannula, Model Number 91228, aa) MC2 29/37 Fr. Two Stage Venous Cannula, Model Number 91229C, bb) MC2 32/40 Fr. Two Stage Venous Cannula, Model Number 91263, cc) MC2 32/40 Fr. Two Stage Venous Cannula, Model Number 91240C, dd) MC2 32/40 Fr. Two Stage Venous Cannula, Model Number 91263C, ee) MC2 34/46 Fr. Two Stage Venous Cannula, Model Number 91246, ff) MC2 34/46 Fr. Two Stage Venous Cannula, Model Number 91246C, gg) MC2 36/46 Fr. Two Stage Venous Cannula, Model Number 91236C, hh) MC2 36/51 Fr. Two Stage Venous Cannula, Model Number 91251, ii) MC2 36/51 Fr. Two Stage Venous Cannula, Model Number 91251C, jj) VC2" 34/38 Fr. Venous Cannula, Model Number 93438, kk) VC2" 34/48 Fr. Venous Cannula, Model Number 93448C

    Recall: Z-1805-2024 · Initiated March 19, 2024

    Recall

    Recall Number
    Z-1805-2024
    Event Number
    94274
    Firm
    Medtronic Perfusion Systems
    FEI Number
    1000116158
    Product Code
    DWF
    Status
    Open, Classified
    Root Cause
    Process control
    Initiated
    March 19, 2024
    Posted
    May 10, 2024
    Address
    7611 Northland Dr N, Brooklyn Park, MN, 55428-1088

    Description

    Medtronic Venous Cannulae: a) DLP 20 Fr. Malleable Single Stage Venous Cannula, Model Number 68120, b) DLP 24 Fr. Malleable Single Stage Venous Cannula, Model Number 68124, c) DLP 28 Fr. Malleable Single Stage Venous Cannula, Model Number 68128, d) DLP 30 Fr. Malleable Single Stage Venous Cannula, Model Number 68130, e) DLP 34 Fr. Malleable Single Stage Venous Cannula, Model Number 68134, f) DLP 12 Fr. Single Stage Venous Cannula, Model Number 67312, g) DLP 16 Fr. Single Stage Venous Cannula, Model Number 67316, h) DLP 16 Fr. Single Stage Venous Cannula, Model Number 67516, i) DLP 18 Fr. Single Stage Venous Cannula, Model Number 66118, j) DLP 18 Fr. Single Stage Venous Cannula, Model Number 67318, k) DLP 20 Fr. Single Stage Venous Cannula, Model Number 67320, l) DLP 20 Fr. Single Stage Venous Cannula, Model Number 69320, m) DLP 20 Fr. Single Stage Venous Cannula, Model Number 67520, n) DLP 22 Fr. Single Stage Venous Cannula, Model Number 66122, o) DLP 22 Fr. Single Stage Venous Cannula, Model Number 67522, p) DLP 24 Fr. Single Stage Venous Cannula, Model Number 67524, q) DLP 26 Fr. Single Stage Venous Cannula, Model Number 67526, r) DLP 28 Fr. Single Stage Venous Cannula, Model Number 66128, s) DLP 28 Fr. Single Stage Venous Cannula, Model Number 39628, t) DLP 28 Fr. Single Stage Venous Cannula, Model Number 67528, u) DLP 30 Fr. Single Stage Venous Cannula, Model Number 66130, v) DLP 31 Fr. Single Stage Venous Cannula, Model Number 69331, w) DLP 32 Fr. Single Stage Venous Cannula, Model Number 66132, x) DLP 34 Fr. Single Stage Venous Cannula, Model Number 67534, y) DLP 36 Fr. Single Stage Venous Cannula, Model Number 66236, z) MC2 28/36 Fr. Two Stage Venous Cannula, Model Number 91228, aa) MC2 29/37 Fr. Two Stage Venous Cannula, Model Number 91229C, bb) MC2 32/40 Fr. Two Stage Venous Cannula, Model Number 91263, cc) MC2 32/40 Fr. Two Stage Venous Cannula, Model Number 91240C, dd) MC2 32/40 Fr. Two Stage Venous Cannula, Model Number 91263C, ee) MC2 34/46 Fr. Two Stage Venous Cannula, Model Number 91246, ff) MC2 34/46 Fr. Two Stage Venous Cannula, Model Number 91246C, gg) MC2 36/46 Fr. Two Stage Venous Cannula, Model Number 91236C, hh) MC2 36/51 Fr. Two Stage Venous Cannula, Model Number 91251, ii) MC2 36/51 Fr. Two Stage Venous Cannula, Model Number 91251C, jj) VC2" 34/38 Fr. Venous Cannula, Model Number 93438, kk) VC2" 34/48 Fr. Venous Cannula, Model Number 93448C

    Reason

    Potential for unsealed sterile packing.

    Action

    Medtronic issued an Urgent Medical Device Recall notice to its consignees on 03/19/2024 via letter (UPS). The notice explained the issue, potential risk, and requested the consignee identify and return the product. Consignee was directed to forward the notice to all affected parties. For questions, the consignee was directed to contact their Medtronic field representative.

    Distribution

    Worldwide distribution.

    Quantity

    17221 units