BEUDAMED
    FDA Recall Terminated

    In-View Clear Leggings Sterile Non-Sterile

    Recall: Z-1301-2021 · Initiated February 25, 2021

    Recall

    Recall Number
    Z-1301-2021
    Event Number
    87431
    Firm
    Cardinal Health 200, LLC
    FEI Number
    3001236905
    Product Code
    ILG
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    February 25, 2021
    Terminated
    January 9, 2024
    Address
    3651 Birchwood Dr, Waukegan, IL, 60085-8337

    Description

    In-View Clear Leggings Sterile 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.

    Action

    A Recall notification letter titled, "URGENT MEDICAL DEVICE RECALL" was sent to consignees on 02/25/2021 via FedEx priority overnight. The consignee is requested to follow the following instructions: 1. CHECK all storage and usage locations to confirm whether they have any units of the affected product codes and lot numbers listed in Attachment 1. 2. SEGREGATE and QUARANTINE all impacted on-hand product. 3) RETURN the enclosed acknowledgment form via facsimile (847-689-9101 or 614-652-9648) or email ([email protected]) and indicate the product code, lot and quantity of product they have quarantined. They are requested to please respond regardless of whether or not they have affected product. 4. NOTIFY any customers to whom they may have distributed, or forwarded product affected by this recall. The consignee's notification to their customers may be enhanced by including a copy of this recall notification letter. 5. CONTACT the appropriate Customer Service group to arrange for return and credit/replacement of any affected product. 6. CUSTOMERS that did not receive product directly from Cardinal Health should return product through the location where they purchased it.

    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

    1020 units