BEUDAMED
    FDA Recall Terminated

    GE Medical Systems, OEC, Vascular Drape, 00-902776-01, Sterile. 150" long x 87" wide. Distributed by GE OEC Medical Systems, Salt Lake City, UT 84116 USA.

    Recall: Z-1706-2009 · Initiated August 15, 2008

    Recall

    Recall Number
    Z-1706-2009
    Event Number
    52561
    Firm
    GE Medical Systems, LLC
    FEI Number
    2126677
    Product Code
    MMP
    Status
    Terminated
    Root Cause
    Packaging process control
    Initiated
    August 15, 2008
    Posted
    September 1, 2009
    Terminated
    May 15, 2012
    Address
    3000 N Grandview Blvd, Waukesha, WI, 53188-1615

    Description

    GE Medical Systems, OEC, Vascular Drape, 00-902776-01, Sterile. 150" long x 87" wide. Distributed by GE OEC Medical Systems, Salt Lake City, UT 84116 USA.

    Reason

    GE Healthcare has found that the sterile products manufactured by Contour Fabricators, Inc. (CFI) for GE healthcare (GEHC) may have seals that could be compromised during the shelf life of the products. This issue could result in the product not maintaining its sterile state. Eleven complaints and 3 MDR's have been filed. No illness or injuries reported.

    Action

    GE Healthcare issued an Urgent Recall Notice dated August 15, 2008. The letter described the problem, provided a list of products, instructed customers to stop using the products and to return or dispose. To receive credit, customers must complete the attached product return form and include it in the package with returned items. All customers were asked to complete and fax back the attached response form.

    Distribution

    Nationwide Distribution -- AZ, CA, FL, MD, NY, OR, PA, SC and TX.

    Quantity

    2760