BEUDAMED
    FDA Enforcement Class II Ongoing

    LSL Healthcare, IV Start Kit, Model/Catalog Number: 3131

    Recall: Z-1932-2026 · Reported April 29, 2026

    Enforcement

    Recall Number
    Z-1932-2026
    Event ID
    98631
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    LSL Healthcare Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    April 29, 2026
    Initiation Date
    March 9, 2026
    Classification Date
    April 22, 2026
    Address
    6200 W Howard St, N/A, Niles, IL, 60714-3404, United States

    Description

    LSL Healthcare, IV Start Kit, Model/Catalog Number: 3131

    Reason

    Medical procedure kits were distributed containing Webcol Large Alcohol Prep Pads which were subsequently recalled for non-sterility.

    Code Info

    Lot Code: Model No. 3131; UDI-DI 00661392054271; Lot#6A3139, Expiration Date 01/21/2028 GTIN: (01)00661392054271(10)6A3139(17)280121

    Distribution

    US Nationwide distribution in the states of MD, IL, MN.

    Quantity

    2200 units