BEUDAMED
    FDA Recall Terminated

    NAMIC (TM) Convenience Kit --- Legal Manufacturer Navilyst Medical, Inc, 26 Forest St, Marlborough, MA 01752 USA --- Made in USA: 10 Glen Falls Technical Park, Glen Falls, NY 12801 USA --- each unit label contains the customer name under the name of the product, and each catalog number is specific to the customer. Product usage: For use in fluid management and/or invasive pressure monitoring systems

    Recall: Z-0821-2012 · Initiated December 19, 2011

    Recall

    Recall Number
    Z-0821-2012
    Event Number
    60729
    Firm
    Navilyst Medical, Inc
    FEI Number
    3017892510
    Product Code
    OEZ
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    December 19, 2011
    Posted
    January 19, 2012
    Terminated
    April 7, 2015
    Address
    10 Glens Falls, Technical Park Glens Falls, NY, 12801

    Description

    NAMIC (TM) Convenience Kit --- Legal Manufacturer Navilyst Medical, Inc, 26 Forest St, Marlborough, MA 01752 USA --- Made in USA: 10 Glen Falls Technical Park, Glen Falls, NY 12801 USA --- each unit label contains the customer name under the name of the product, and each catalog number is specific to the customer. Product usage: For use in fluid management and/or invasive pressure monitoring systems

    Reason

    Navilyst Medical has received reports of damaged manifolds contained in certain NAMIC Convenience Kits which may result in air injection during certain procedures.

    Action

    Navilyst Medical sent an Urgent Medical Device Recall- Immediate Action Required letter dated December 19, 2011 and a Reply Verification Tracking Form to all affected consignees via Federal Express or email. The letter identified the product, description of problem, and actions to be taken Customers were instructed to 1) IMMEDIATELY DISCONTINUE USE; 2) remove the recalled product from your inventory (whether in Labs, Central Supply, Shipping and Receiving or ANY other location); 3) segregate this product in a secure location for return to Navilyst Medical, Inc; 4) immediately forward a copy of this recall notification to all sites to which you have distributed affected product; 5) complete and return the Reply Verification Tracking Form; and 6) package and return the recalled product per the instruction provided.

    Distribution

    Worldwide Distribution - USA (nationwide) including the states of Connecticut, Florida, Illinois, Indiana, Kentucky, Maryland, Michigan, New Jersey, New York, Ohio, South Carolina, Wisconsin, Virginia and the country of Japan.

    Quantity

    4547