BEUDAMED
    FDA Enforcement Class II Ongoing

    DeRoyal CARDIAC CATH SET-UP KIT PGYBK, REF 89-10572

    Recall: Z-0622-2024 · Reported January 3, 2024

    Enforcement

    Recall Number
    Z-0622-2024
    Event ID
    93520
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    DeRoyal Industries Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    January 3, 2024
    Initiation Date
    November 22, 2023
    Classification Date
    December 28, 2023
    Address
    200 Debusk Ln, Powell, TN, 37849-4703, United States

    Description

    DeRoyal CARDIAC CATH SET-UP KIT PGYBK, REF 89-10572

    Reason

    Kit were manufactured and distributed with Edwards Life Sciences TruWave Disposable pressure transducers which were subsequently recalled by Edwards Life Sciences.

    Code Info

    GTIN 00749756364065, Serial Numbers: '59716839, '59867186

    Distribution

    US: Virginia

    Quantity

    252 units