BEUDAMED
    FDA Recall Terminated

    Various SRI Surgical Disposable Accessory Packs. SRI's Disposable Accessory Packs (also commonly known as convenience kits and custom procedure trays) are an assembly of medical devices packaged together according to the customer specifications, which are then wrapped in a sterilization wrap and sterilized. This allows the customer to open one package for a surgical procedure instead of many individual packages.

    Recall: Z-2300-2012 · Initiated July 16, 2008

    Recall

    Recall Number
    Z-2300-2012
    Event Number
    49060
    Firm
    SRI Surgical
    FEI Number
    1000113384
    Product Code
    FTN
    Status
    Terminated
    Root Cause
    Component change control
    Initiated
    July 16, 2008
    Posted
    August 29, 2012
    Terminated
    September 10, 2012
    Address
    12425 Race Track Rd, Tampa, FL, 33626-3118

    Description

    Various SRI Surgical Disposable Accessory Packs. SRI's Disposable Accessory Packs (also commonly known as convenience kits and custom procedure trays) are an assembly of medical devices packaged together according to the customer specifications, which are then wrapped in a sterilization wrap and sterilized. This allows the customer to open one package for a surgical procedure instead of many individual packages.

    Reason

    Distribution of a product that did not meet specifications. (labeling error)

    Action

    SRI sent a "MEDICAL DEVICE CORRECTION" letter dated July 16, 2008 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. Contact the firm at 813-891-9550 ext. 3124 for questions regarding this recall.

    Distribution

    Nationwide Distribution-including the states of CA, FL, GA, KY, MD, MI, NC, NJ, OK, PA, SC, TN, TX, and UT.

    Quantity

    802,135