BEUDAMED
    FDA Enforcement Class II Ongoing

    SteriPack Sterile Polyester Spun Swabs (25 units/Pack)- Intended for sample collection in the intended nasal area. Catalog Number: 60566RevB

    Recall: Z-1970-2023 · Reported June 21, 2023

    Enforcement

    Recall Number
    Z-1970-2023
    Event ID
    92334
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    LumiraDx
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    June 21, 2023
    Initiation Date
    April 25, 2023
    Classification Date
    June 15, 2023
    Address
    221 Crescent St, N/A, Waltham, MA, 02453-3475, United States

    Description

    SteriPack Sterile Polyester Spun Swabs (25 units/Pack)- Intended for sample collection in the intended nasal area. Catalog Number: 60566RevB

    Reason

    Fails Post-Sterilization Sterile Swabs Cantilever (Bend) Testing and may be more susceptible to breakage. If the swab breaks in the nasal cavity of a patient may cause injury or medical intervention to remove part of the swab

    Code Info

    GTIN-DI: 00850027193205 Pack Lot Number : 85438; Individual Swab Lot Number: 86445 Exp Date: 28-Oct-2023

    Distribution

    US Nationwide distribution.

    Quantity

    1003 kits