BEUDAMED
    FDA Recall Terminated

    NAMIC Convenience Kit, DYE CATH LAB KIT, UPN H749601367131, REF/Catalog No. 60136713, STERILE, Rx ONLY --- For single use only. --- Device Listing Number D136588. Product Usage: NAMIC Convenience Kits are intended to be used in Fluid Management and/or Invasive Pressure Monitoring Systems.

    Recall: Z-1173-2015 · Initiated January 9, 2015

    Recall

    Recall Number
    Z-1173-2015
    Event Number
    70322
    Firm
    Navilyst Medical, Inc
    FEI Number
    3017892510
    Product Code
    OEQ
    Status
    Terminated
    Root Cause
    Packaging
    Initiated
    January 9, 2015
    Posted
    February 26, 2015
    Terminated
    March 10, 2017
    Address
    10 Glens Falls, Technical Park Glens Falls, NY, 12801

    Description

    NAMIC Convenience Kit, DYE CATH LAB KIT, UPN H749601367131, REF/Catalog No. 60136713, STERILE, Rx ONLY --- For single use only. --- Device Listing Number D136588. Product Usage: NAMIC Convenience Kits are intended to be used in Fluid Management and/or Invasive Pressure Monitoring Systems.

    Reason

    The labelled expiration dating of the affected product is not fully supported by shelf life verification testing, which may result in a sterility breach. Use of a Fluid Management Convenience Kit, where sterility has been breached, may result in an increased risk of infection.

    Action

    Navilyst Medical sent an Urgent Medical Device Recall Notification letter dated January 9, 2015 to US customers (end users) via Federal Express. On January 20, 2015, Recall Notification Packages were sent via Federal Express to 2 International consignees (distributors). the letter identified the affected product, problem and actions to be taken. Customers are instructed to: " Immediately remove the recall product from your inventory (whether in labs, Central Supply, Shipping and Receiving or ANY other location). " Segregate this product in a secure location for return to Navilyst Medical. " Immediately forward a copy of this recall notification to all sites to which you have distributed affected product. " Complete and return the Reply Verification Tracking Form.

    Distribution

    Worldwide Distribution - US Nationwide and the countries of: Canada, and Guam.

    Quantity

    512 units