BEUDAMED
    FDA Enforcement Class II Ongoing

    stryker Sage PrimaFit External Urine Management System for the Female Anatomy

    Recall: Z-0356-2024 · Reported November 29, 2023

    Enforcement

    Recall Number
    Z-0356-2024
    Event ID
    93229
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Sage Products Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 29, 2023
    Initiation Date
    October 23, 2023
    Classification Date
    November 20, 2023
    Address
    3909 3 Oaks Rd, N/A, Cary, IL, 60013-1804, United States

    Description

    stryker Sage PrimaFit External Urine Management System for the Female Anatomy

    Reason

    A small percentage of devices in three lots of product may contain a tape with a natural rubber latex adhesive which is not declared on the label

    Code Info

    GTIN 00618029600417, Lot Codes: 93667, 93614, 93613

    Distribution

    US and Canada

    Quantity

    174,960 devices