BEUDAMED
    FDA Recall Terminated

    Aesculap Sterile disposable fleece drape, Product code: GA414, individually packaged, 50 pieces per shipping unit, product code SZ380R.

    Recall: Z-1449-2022 · Initiated October 1, 2019

    Recall

    Recall Number
    Z-1449-2022
    Event Number
    90475
    Firm
    Aesculap Implant Systems LLC
    FEI Number
    2916714
    Product Code
    PUI
    Status
    Terminated
    Root Cause
    Package design/selection
    Initiated
    October 1, 2019
    Terminated
    June 6, 2024
    Address
    3773 Corporate Pkwy, Center Valley, PA, 18034-8217

    Description

    Aesculap Sterile disposable fleece drape, Product code: GA414, individually packaged, 50 pieces per shipping unit, product code SZ380R.

    Reason

    Packaging seal integrity not validated resulting in a lack of sterility assurance.

    Action

    Recall notice issued October 1, 2019 via letter mailed USPS certified mail with return receipt. Customers are to review inventory, return affected product and the acknowledgement form. For questions contact (800) 282-9000 or email: [email protected]

    Distribution

    United States: CA, CO, GA, IL, IN, KY, MI, NC, NE, NY, OH, RI, VA and WI

    Quantity

    4500 pieces