BEUDAMED
    FDA Recall Open, Classified

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

    Recall: Z-0326-2023 · Initiated October 21, 2022

    Recall

    Recall Number
    Z-0326-2023
    Event Number
    91079
    Firm
    Busse Hospital Disposables, Inc.
    FEI Number
    2433012
    Product Code
    OGJ
    Status
    Open, Classified
    Root Cause
    Device Design
    Initiated
    October 21, 2022
    Posted
    November 29, 2022
    Address
    75 Arkay Dr, Hauppauge, NY, 11788-3707

    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

    Action

    Busse issued Product Recall Notification Letter dated 10/20/22 to Distributor; End User via Email on 10/21/2022 and Certified Mail on 10/24/2022 Letter states reason for recall, health risk and action to take: 1. Immediately check your inventory for the lots listed above. 2. Do not use the drape included in the product with the lot number(s) listed above. 3. Complete the enclosed Response Form within the next 10 days and return via email to [email protected] even if you have no affected product on hand. a. If you do have product in stock, destroy the drape following your facility policy.

    Distribution

    TX

    Quantity

    40 cases