BEUDAMED
    FDA Recall Terminated

    XGAUZE Trauma Dressing, catalog number FIN-0002-01. XGAUZE is a 3" x 36" z-folded rayon/polyester dressing embedded with individual compressed cellulose sponges. Upon contact with blood or exudate, the sponges expand, thus increasing the dressing's capacity to absorb fluids. XGAUZE is packed in a pre-formed sterile barrier system (pouch sealed on three sides); one side is a PET/foil/PE film, and the other side is a PET/aluminum oxide/PE film. Packages are vacuum sealed and terminally sterilized via gamma radiation.

    Recall: Z-2762-2015 · Initiated August 12, 2015

    Recall

    Recall Number
    Z-2762-2015
    Event Number
    72019
    Firm
    Revmedx Inc
    FEI Number
    3009035955
    Product Code
    NAB
    Status
    Terminated
    Root Cause
    Package design/selection
    Initiated
    August 12, 2015
    Posted
    September 11, 2015
    Terminated
    September 17, 2015
    Address
    25999 Sw Canyon Creek Rd, Wilsonville, OR, 97070-9677

    Description

    XGAUZE Trauma Dressing, catalog number FIN-0002-01. XGAUZE is a 3" x 36" z-folded rayon/polyester dressing embedded with individual compressed cellulose sponges. Upon contact with blood or exudate, the sponges expand, thus increasing the dressing's capacity to absorb fluids. XGAUZE is packed in a pre-formed sterile barrier system (pouch sealed on three sides); one side is a PET/foil/PE film, and the other side is a PET/aluminum oxide/PE film. Packages are vacuum sealed and terminally sterilized via gamma radiation.

    Reason

    The XGAUZE Trauma Dressing was recalled because the packages may acquire small tears or pinholes during shipping due to use of shipping containers that lacked adequate protective materials. If present, these small tears or pinholes may disrupt package integrity and render the device unsterile.

    Action

    RevMedx, Inc. sent the Urgent Medical Device Correction and Removal XGAUZE Trauma Dressing letter to US Customers on August 12, 2015. Customers are instructed to inspect packages for signs of damages or loss of vacuum. The affected packages will appear puffy and the dressing will be loose inside. The non-affected packages will have a good vacuum intact seal and the packaging material should contour snugly against the dressing. Customers are advised to return any packages appear to have damaged or loss of vacuum. Any undamaged packages may be used as indicated. Customers with question can call the firm at (503) 218-2172 and fax the Return Response Form via fax to (503) 218-2274 or send via email to [email protected].

    Distribution

    US Distribution to the states of : Arizona, Idaho, North Carolina, Tennessee and Virginia.

    Quantity

    5004 units