BEUDAMED
    FDA Enforcement Class II Ongoing

    Precision Delivery Set with Filter, REF: PD06F; and Precision Delivery Set with Trifurcated Luer, REF: PDT05CV2

    Recall: Z-1100-2023 · Reported February 15, 2023

    Enforcement

    Recall Number
    Z-1100-2023
    Event ID
    91409
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Quest Medical, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 15, 2023
    Initiation Date
    December 23, 2022
    Classification Date
    February 7, 2023
    Address
    1 Allentown Pkwy, Allen, TX, 75002-4206, United States

    Description

    Precision Delivery Set with Filter, REF: PD06F; and Precision Delivery Set with Trifurcated Luer, REF: PDT05CV2

    Reason

    Delivery Sets may have tubing that could become detached that could result in patient infection.

    Code Info

    REF/UDI-DI/Lots (Expiration Dates): PD06F/00634624911062/65824 (4/18/2025), 65826 (4/18/2025), 66069 (5/16/2025); PDT05CV2/00634624921412/66645 (7/11/2025)

    Distribution

    US Nationwide distribution in the state of MA.

    Quantity

    13,900