BEUDAMED
    FDA Enforcement Class II Terminated

    In-View Clear Leggings Bulk Non-Sterile

    Recall: Z-1302-2021 · Reported March 31, 2021

    Enforcement

    Recall Number
    Z-1302-2021
    Event ID
    87431
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Cardinal Health 200, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 31, 2021
    Initiation Date
    February 25, 2021
    Classification Date
    March 24, 2021
    Termination Date
    January 9, 2024
    Address
    3651 Birchwood Dr, N/A, Waukegan, IL, 60085-8337, United States

    Description

    In-View Clear Leggings Bulk Non-Sterile

    Reason

    Cardinal Health has determined that a manufacturing variance in a plastic film used to manufacture these products is causing the drapes and leggings to stick , which may prevent the products from being unfolded and applied properly.

    Code Info

    Catalog Number 8430NA; Lot number's: 2460DR2, 2550DR1, 2660DR1, 2470DR2, 2580DR1, 2690DR1, 2480DR2, 2580DR2, 2720DR1, 2520DR1, 2600DR1, 2730DR1, 2530DR1, 2600DR1, 3290DR1, 2540DR1, 2610DR1 3310DR1, 2540DR2, 2650DR1, 3440DR1

    Distribution

    Distributed nationwide to AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV. Distributed also to Australia and Canada.

    Quantity

    21343 units