BEUDAMED
    FDA Recall Open, Classified

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

    Recall: Z-0622-2024 · Initiated November 22, 2023

    Recall

    Recall Number
    Z-0622-2024
    Event Number
    93520
    Firm
    DeRoyal Industries Inc
    FEI Number
    1043214
    Product Code
    LRO
    Status
    Open, Classified
    Root Cause
    Device Design
    Initiated
    November 22, 2023
    Posted
    September 30, 2024
    Address
    200 Debusk Ln, Powell, TN, 37849-4703

    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.

    Action

    DeRoyal Industries issued am URGENT FIELD CORRECTIVE ACTION notice to its sole consignee on 11/22/2023 via email. The notice explained the issue and provided instructions on the proper use of the device.

    Distribution

    US: Virginia

    Quantity

    252 units