BEUDAMED
    FDA Recall Terminated

    TMJ Arthroscopy Drape, 85''x 96''

    Recall: Z-1071-2022 · Initiated April 8, 2022

    Recall

    Recall Number
    Z-1071-2022
    Event Number
    89956
    Firm
    Microtek Medical Inc.
    FEI Number
    3014342658
    Product Code
    PUI
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    April 8, 2022
    Terminated
    June 5, 2024
    Address
    1 Ecolab Pl, Saint Paul, MN, 55102-2739

    Description

    TMJ Arthroscopy Drape, 85''x 96''

    Reason

    Latex content in product was labeled incorrectly as latex free.

    Action

    All consignees were contacted on 04/08/2022 via email. Consignees should read the recall instruction, examine their inventory, and quarantine the lots listed in the letter. The consignees should also complete the enclosed response form and email it to [email protected]. If the consignee has further distributed the product, they should identify and notify their customers of the recall.

    Distribution

    Distributed nationwide to CO, PA, and WI.

    Quantity

    12 cases (120 drapes)