BEUDAMED
    FDA Enforcement Class II Ongoing

    DeRoyal REF 71-C5100NS Tubing, Suction, Connector; DeRoyal REF 71-C6100NS Tubing, Suction, Connector; DeRoyal REF 71-C7100NS Tubing, Suction, Connector Indicated use - Fluid Movement

    Recall: Z-1291-2025 · Reported March 12, 2025

    Enforcement

    Recall Number
    Z-1291-2025
    Event ID
    96261
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    DeRoyal Industries Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 12, 2025
    Initiation Date
    January 31, 2025
    Classification Date
    March 5, 2025
    Address
    200 Debusk Ln, Powell, TN, 37849-4703, United States

    Description

    DeRoyal REF 71-C5100NS Tubing, Suction, Connector; DeRoyal REF 71-C6100NS Tubing, Suction, Connector; DeRoyal REF 71-C7100NS Tubing, Suction, Connector Indicated use - Fluid Movement

    Reason

    Due to the inner diameter of the suction tubing connector being smaller than the suction canister lid port connection. This size difference, combined with the durometer of the plastic material, makes the assembly to a suction canister lid port difficult. This could result in inadequate suction and cause a delay in patient care.

    Code Info

    71-C5100NS Bulk Roll Suction Connector Tubing UDI-DI code: 00749756578738 Lot Number: CNWKD04-04 71-C6100NS Bulk Roll Suction Connector Tubing UDI-DI code: 00749756578851 Lot Numbers: CNWKD04-04 CNWKD04-05 CNWKD04-10 CNWKD09-08 71-C7100NS Bulk Roll Suction Connector Tubing UDI-DI code: 00749756578967 Lot Numbers: CNWKD04-06 CNWKD04-07

    Distribution

    U.S.: IL, MN, NC, PA, and VA O.U.S.: N/A

    Quantity

    714 cases