BEUDAMED
    FDA Enforcement Class II Ongoing

    Custom medical procedure packs labeled as: a) CATH ANGIOGRAPHY DRAPE PACK, REF 89-7102; b) CHOLANGIOGRAPHY KIT, REF 89-7322; c) CATH LAB PACK, REF 89-9183

    Recall: Z-2090-2023 · Reported July 12, 2023

    Enforcement

    Recall Number
    Z-2090-2023
    Event ID
    92445
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    DeRoyal Industries Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    July 12, 2023
    Initiation Date
    May 30, 2023
    Classification Date
    July 3, 2023
    Address
    200 Debusk Ln, N/A, Powell, TN, 37849-4703, United States

    Description

    Custom medical procedure packs labeled as: a) CATH ANGIOGRAPHY DRAPE PACK, REF 89-7102; b) CHOLANGIOGRAPHY KIT, REF 89-7322; c) CATH LAB PACK, REF 89-9183

    Reason

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

    Code Info

    a) REF 89-7102, GTIN 50749756734085 (cs), 00749756734080 (unit), Lot Numbers: 58806701; b) REF 89-7322, GTIN 50749756736171 (cs), 00749756736176 (unit), Lot Numbers: 58821231; c) REF 89-9183, GTIN '0749756904846 (cs), 00749756904841 (unit), Lot Numbers: 58741944

    Distribution

    US Nationwide distribution.

    Quantity

    306 packs