BEUDAMED
    FDA Enforcement Class II Terminated

    DeRoyal DEXMED ACCESS CENTER TRAY, containing Prevantics antiseptic (chlorhexidine gluconate and isopropyl alcohol) swab, for preparation of the patient skin prior to surgery or injection.

    Recall: Z-0880-2022 · Reported April 13, 2022

    Enforcement

    Recall Number
    Z-0880-2022
    Event ID
    89737
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    DeRoyal Industries Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 13, 2022
    Initiation Date
    March 3, 2022
    Classification Date
    April 6, 2022
    Termination Date
    September 15, 2022
    Address
    200 Debusk Ln, Powell, TN, 37849-4703, United States

    Description

    DeRoyal DEXMED ACCESS CENTER TRAY, containing Prevantics antiseptic (chlorhexidine gluconate and isopropyl alcohol) swab, for preparation of the patient skin prior to surgery or injection.

    Reason

    A kit component, the PDI Prevantics Swab was recalled due to uncertain validation of test methods used to manufacture the products.

    Code Info

    SKU/Part Number 89-5300.07; UDI 00749756632317 Lot Numbers (Expiration Date): Lot 53059743 (exp 06/01/2022), Lot 53632941 (exp 06/01/2022), Lot 53666113 (exp 06/01/2022), Lot 54205909 (exp 06/01/2022), Lot 54279422 (exp 06/01/2022), Lot 54327332 (exp 06/01/2022), Lot 54473313 (exp 06/01/2022), Lot 55573404 (exp 06/01/2022)

    Distribution

    US distribution to Florida, New Jersey, and Tennessee

    Quantity

    1360 kits