BEUDAMED
    FDA Enforcement Class II Ongoing

    Busse SPINE INJECTION TRAY-Intended as a nerve block REF No. 8563R1

    Recall: Z-0326-2023 · Reported December 7, 2022

    Enforcement

    Recall Number
    Z-0326-2023
    Event ID
    91079
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Busse Hospital Disposables, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 7, 2022
    Initiation Date
    October 21, 2022
    Classification Date
    November 29, 2022
    Address
    75 Arkay Dr, Hauppauge, NY, 11788-3707, United States

    Description

    Busse SPINE INJECTION TRAY-Intended as a nerve block REF No. 8563R1

    Reason

    Kits containing 3M Steri-Drape Surgical Drapes recalled by 3M due to liner on the adhesive component is difficult to remove without damaging the product and may render the product unusable

    Code Info

    UDI-DI: (01) 00849233016705 Lot Number: 2230458

    Distribution

    TX

    Quantity

    40 cases