BEUDAMED
    FDA Enforcement Class II Ongoing

    NuStat 8" x12" Trauma Pad XR Hemafiber, 5-pack. For temporary control of internal organ space bleeding REF: XR-0812-5

    Recall: Z-0309-2022 · Reported December 8, 2021

    Enforcement

    Recall Number
    Z-0309-2022
    Event ID
    88941
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Beeken Biomedical, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    December 8, 2021
    Initiation Date
    October 14, 2021
    Classification Date
    November 26, 2021
    Address
    378 Page St Ste 201, Stoughton, MA, 02072-1124, United States

    Description

    NuStat 8" x12" Trauma Pad XR Hemafiber, 5-pack. For temporary control of internal organ space bleeding REF: XR-0812-5

    Reason

    Endotoxin levels exceeded allowable limits.

    Code Info

    Lot Code: 20C015 UDI: 00850392006544

    Distribution

    US in the state of MO

    Quantity

    15 units