BEUDAMED
    FDA Recall Terminated

    AxoTrack I Sterile Procedure Kit 18G, K1001-18XTW, (24/case labeled for US, 5/case labeled for US, 24/case labeled for EU, 5/case labeled for EU). Sterile Procedure Kit for use AxoTrack enabled Ultrasound Transducer for magnetic needle tracking.

    Recall: Z-0215-2015 · Initiated March 24, 2014

    Recall

    Recall Number
    Z-0215-2015
    Event Number
    69619
    Firm
    Soma Access Systems LLC
    FEI Number
    3009436116
    Product Code
    IYO
    Status
    Terminated
    Root Cause
    Packaging
    Initiated
    March 24, 2014
    Posted
    December 16, 2014
    Terminated
    August 6, 2015
    Address
    109 Laurens Rd, Ste 4c, Greenville, SC, 29607-1860

    Description

    AxoTrack I Sterile Procedure Kit 18G, K1001-18XTW, (24/case labeled for US, 5/case labeled for US, 24/case labeled for EU, 5/case labeled for EU). Sterile Procedure Kit for use AxoTrack enabled Ultrasound Transducer for magnetic needle tracking.

    Reason

    There is a possibility the sterile packaging may fail before the expiration date specified on the package.

    Action

    Consignees were notified via USPS Certified Letter, email and FedEx on 3/24/2014.

    Distribution

    Worldwide Distribution-US (nationwide) including the states of AL, AZ, CA, CT, FL, GA, IN, KY, LA, MA, MI, MO, NC, NJ, NY OH, OR, PA, SC, TN, TX, VA, and WA and the countries of Belgium, Hong Kong, India, Japan, Panama and Singapore.

    Quantity

    3530 units