BEUDAMED
    FDA Recall Terminated

    HEMASHIELD Knitted Double Velour Cardiovascular Fabric

    Recall: Z-1172-2018 · Initiated January 3, 2018

    Recall

    Recall Number
    Z-1172-2018
    Event Number
    79536
    Firm
    GETINGE US SALES LLC
    FEI Number
    3012092534
    Product Code
    DXZ
    Status
    Terminated
    Root Cause
    Labeling mix-ups
    Initiated
    January 3, 2018
    Posted
    March 20, 2018
    Terminated
    July 3, 2018
    Address
    45 Barbour Pond Dr, Wayne, NJ, 07470-2094

    Description

    HEMASHIELD Knitted Double Velour Cardiovascular Fabric

    Reason

    A probable mislabeling of the product: a different-sized product is referenced on the product packaging label (i.e. 2.5 cm (width) x 7.6 cm (length)) while the actual product inside the box is 2.5 cm (width) x 15 cm (length).

    Action

    On January 3, 2018 an URGENT MEDICAL DEVICE RECALL NOTICE was issued to the (1) affected customer. A return authorization was issued with the recall letter, which is intended to be returned to the recalling firm. Questions or concerns can be directed to 1-800-528-7486

    Distribution

    FL

    Quantity

    1