BEUDAMED
    FDA Recall Open, Classified

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

    Recall: Z-1100-2023 · Initiated December 23, 2022

    Recall

    Recall Number
    Z-1100-2023
    Event Number
    91409
    Firm
    Quest Medical, Inc.
    FEI Number
    3001665800
    Product Code
    FPA
    Status
    Open, Classified
    Root Cause
    Process control
    Initiated
    December 23, 2022
    Posted
    February 7, 2023
    Address
    1 Allentown Pkwy, Allen, TX, 75002-4206

    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.

    Action

    On 12/23/22, the recall notice was distributed. The customer was asked to return affected devices and to call 1-800-627-0226, extension 311, if they had any questions.

    Distribution

    US Nationwide distribution in the state of MA.

    Quantity

    13,900