BEUDAMED
    FDA Enforcement Class II Terminated

    TMJ Arthroscopy Drape, 85''x 96''

    Recall: Z-1071-2022 · Reported May 18, 2022

    Enforcement

    Recall Number
    Z-1071-2022
    Event ID
    89956
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Microtek Medical Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 18, 2022
    Initiation Date
    April 8, 2022
    Classification Date
    May 12, 2022
    Termination Date
    June 5, 2024
    Address
    1 Ecolab Pl, N/A, Saint Paul, MN, 55102-2739, United States

    Description

    TMJ Arthroscopy Drape, 85''x 96''

    Reason

    Latex content in product was labeled incorrectly as latex free.

    Code Info

    SKU Number 3601; Lot code/Expiration Date: Lot D181232, exp. 05/01/2022; Lot D181982, exp. 07/01/2022; Lot D202232, exp.08/01/2024; Lot D210742, exp. 03/01/2025; Lot D211372, exp. 05/01/2025; Lot D212562, exp. 09/01/2025; Lot D213122, exp. 11/01/2025; and Lot D213402, exp. 12/01/2025. UDI: 50748426008556

    Distribution

    Distributed nationwide to CO, PA, and WI.

    Quantity

    12 cases (120 drapes)