BEUDAMED
    FDA Recall Terminated

    TriActiv System Balloon Inflation Syringe. The syringe packs/boxes contain 5 'spare' syringes.

    Recall: Z-1221-06 · Initiated May 24, 2006

    Recall

    Recall Number
    Z-1221-06
    Event Number
    35680
    Firm
    Kensey Nash Corp
    FEI Number
    1000307073
    Product Code
    NFA
    Status
    Terminated
    Root Cause
    Other
    Initiated
    May 24, 2006
    Posted
    July 12, 2006
    Terminated
    July 11, 2006
    Address
    735 Pennsylvania Dr, Exton, PA, 19341-1130

    Description

    TriActiv System Balloon Inflation Syringe. The syringe packs/boxes contain 5 'spare' syringes.

    Reason

    volume control knob not able to go up to larger diameters

    Action

    A letter was issued to the sales representative that have customers which received affected product, 5/24/2006. Sales representatives visited their sites within 3 days to determine if the affected product was still in inventory. If the product was still in inventory the sales representative provided the trained TriActiv System user(s) a Technical Bulletin that instructed the users how to correct the knob position.

    Distribution

    Nationwide. The products are shipped to hospitals in AL, DE, Fl, IL, IN, MI, PA, SC, TN and TX.

    Quantity

    15 boxes