BEUDAMED
    FDA Recall Terminated

    DeRoyal Sterile Custom Kits containing ICU Medical MicroClave Clear Connectors

    Recall: Z-1668-2022 · Initiated August 12, 2022

    Recall

    Recall Number
    Z-1668-2022
    Event Number
    90749
    Firm
    DeRoyal Industries Inc
    FEI Number
    1043214
    Product Code
    LRO
    Status
    Terminated
    Root Cause
    Material/Component Contamination
    Initiated
    August 12, 2022
    Terminated
    September 20, 2024
    Address
    200 Debusk Ln, Powell, TN, 37849-4703

    Description

    DeRoyal Sterile Custom Kits containing ICU Medical MicroClave Clear Connectors

    Reason

    Procedure packs contained a recalled product.

    Action

    DeRoyal issued their recall notification on 08/12/2022 to the end user level by emailing recall letters to affected consignees. The consignees are asked to identify the affected products and return any affected product and to complete the return form back to DeRoyal.

    Distribution

    US Nationwide distribution in the states of OH and TN.

    Quantity

    1306 kits