BEUDAMED
    FDA Recall Terminated

    HiZel, Trayless-sterile hydrogel wound dressing. Sizes 2.4 x 2.4'', 2.4 x 4.7'', & 4.7 x 4.7''. Product is a transparent, flexible sheet. Packaged in a peelable pouch.

    Recall: Z-0455-2007 · Initiated November 9, 2006

    Recall

    Recall Number
    Z-0455-2007
    Event Number
    36831
    Firm
    Embeem Inc.
    FEI Number
    3005089721
    Product Code
    NAE
    Status
    Terminated
    Root Cause
    Other
    Initiated
    November 9, 2006
    Posted
    January 17, 2007
    Terminated
    July 21, 2008
    Address
    18 Ireland Brook Dr N, Brunswick, NJ, 08902-4761

    Description

    HiZel, Trayless-sterile hydrogel wound dressing. Sizes 2.4 x 2.4'', 2.4 x 4.7'', & 4.7 x 4.7''. Product is a transparent, flexible sheet. Packaged in a peelable pouch.

    Reason

    Foreign material- this device, a sterile wound care product, was found to be contaminated with clumps of brown/black foreign material

    Action

    Recall letters were sent out on 11/9/2006 to the retail level

    Distribution

    There are 47 customers which includes two large distributors/accounts and the rest are internet individual purchasers. These internet purchases amounts are 6 to 18 pieces at a time. There are no government accounts and no international accounts generating from EMBEEM.

    Quantity

    1,258 pieces