BEUDAMED
    FDA Enforcement Class II 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 · Reported November 26, 2014

    Enforcement

    Recall Number
    Z-0215-2015
    Event ID
    69619
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Soma Access Systems LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 26, 2014
    Initiation Date
    March 24, 2014
    Classification Date
    November 14, 2014
    Termination Date
    August 6, 2015
    Address
    109 Laurens Rd Ste 4c, N/A, Greenville, SC, 29607-1860, United States

    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.

    Code Info

    Product Ref#70956, Lot #62191-000, Expiration Date: 2/28/2014, Lot #62193-000, Expiration Date: 2/28/2014, Lot #62360-000, Expiration Date: 2/28/2014, Lot #62922-000, Expiration Date: 4/30/2014, Lot #63191-000 and Expiration Date: 10/31/2014 (24/case labeled for US); Product Ref#70957, Lot # 62188-000, Expiration Date: 2/28/2014, Lot # 62435-000, Expiration Date: 2/28/2014, Lot # 62489-000 Expiration Date: 3/31/2014 and Lot # 63191-000, Expiration Date: 10/31/2014 (5/case labeled for US); Product Ref#71489, Lot # 63191-000, Expiration Date: 10/31/2014 (24/case labeled for EU) and Product Ref#71489, Lot # 62489-000, Expiration Date: 3/31/2014, Lot # 62529-000, Expiration Date: 3/31/2014 and Lot # 63191-000 Expiration Date: 10/31/2014 (5/case labeled for EU).

    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