BEUDAMED
    FDA Enforcement Class II Ongoing

    HAND DRAPING SJH-Procedure Kit Catalog Number: SJHD67F

    Recall: Z-2300-2024 · Reported July 17, 2024

    Enforcement

    Recall Number
    Z-2300-2024
    Event ID
    94765
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    American Contract Systems Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    July 17, 2024
    Initiation Date
    May 15, 2024
    Classification Date
    July 5, 2024
    Address
    85 Shaffer Park Dr, N/A, Tiffin, OH, 44883-9290, United States

    Description

    HAND DRAPING SJH-Procedure Kit Catalog Number: SJHD67F

    Reason

    Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual limits for permanent exposure devices as indicated by ANSI/AAMI/ISO 10993-7/(R)2012.

    Code Info

    UDI-DI: 00191072192349 LOT#"s: 662231 981241 917241 882241

    Distribution

    US Nationwide distribution.

    Quantity

    352 units