BEUDAMED
    FDA Recall Open, Classified

    Custom medical procedure packs labeled as: a) STANDARD OB PACK ASCENSION WI, REF 89-10640 b) ANGIO PACK, REF 89-10901 c) BASIN, REF 89-1924 d) CYSTO PACK, REF 89-7133 e) TOTAL HIP PACK, REF 89-9134 f) EMERGENCY C-SECTION PACK, REF 89-9478

    Recall: Z-2088-2023 · Initiated May 30, 2023

    Recall

    Recall Number
    Z-2088-2023
    Event Number
    92445
    Firm
    DeRoyal Industries Inc
    FEI Number
    1043214
    Product Code
    KDD
    Status
    Open, Classified
    Root Cause
    Process control
    Initiated
    May 30, 2023
    Posted
    July 3, 2023
    Address
    200 Debusk Ln, Powell, TN, 37849-4703

    Description

    Custom medical procedure packs labeled as: a) STANDARD OB PACK ASCENSION WI, REF 89-10640 b) ANGIO PACK, REF 89-10901 c) BASIN, REF 89-1924 d) CYSTO PACK, REF 89-7133 e) TOTAL HIP PACK, REF 89-9134 f) EMERGENCY C-SECTION PACK, REF 89-9478

    Reason

    The outer package seal could be open, or compromised which affects the sterility of the procedure pack inside.

    Action

    DeRoyal disseminated an URGENT! DEROYAL RECALL NOTICE to its consignees on 05/30/2023 by email. The notice explained the issue, the risk, and requested the return of the affected products. Distributors were also directed to identify and notify their customers.

    Distribution

    US Nationwide distribution.

    Quantity

    328 packs