BEUDAMED
    FDA Recall Terminated

    12ml Control Syringe / Smart Tip, REF/CAT No.: ST601, Sterile EO, Merit Medical Systems, Inc., South Jordan, Utah 84095. The product is used for injections of contrast medium during Coronary or Peripheral Angiography and Angioplasty.

    Recall: Z-2368-2008 · Initiated July 9, 2008

    Recall

    Recall Number
    Z-2368-2008
    Event Number
    49002
    Firm
    Merit Medical Systems, Inc.
    FEI Number
    1721504
    Product Code
    FMF
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    July 9, 2008
    Posted
    September 21, 2008
    Terminated
    November 3, 2008
    Address
    1600 Merit Pkwy South, Jordan, UT, 84095

    Description

    12ml Control Syringe / Smart Tip, REF/CAT No.: ST601, Sterile EO, Merit Medical Systems, Inc., South Jordan, Utah 84095. The product is used for injections of contrast medium during Coronary or Peripheral Angiography and Angioplasty.

    Reason

    Control Syringes may be non-sterile due to holes in the packaging.

    Action

    Urgent Product Recall letters dated 07/09/08, were faxed on 07/09/2008 to consignees/sales reps. The letter instructed consignees/sales reps to contact their customers by phone or visit to provide recall information and instructions. Customers were told to immediately discontinue use and to quarantine all affected products. A Product Retrieval Form was provided that was to be signed by the site representative. Contact Merit Medical at 1-801-208-4408 for assistance.

    Distribution

    CA, FL, GA, ID, IL, IN, KS, LA, MO, MT, OH, PA, TN, and WA. Foreign distribution to Japan.

    Quantity

    100 units