Events

Recall of Device Recall AxoTrack I Sterile Procedure Kit, 18G (K100118XTW)

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Soma Access Systems LLC.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    69619
  • Event Risk Class
    Class 2
  • Event Number
    Z-0215-2015
  • Event Initiated Date
    2014-03-24
  • Event Date Posted
    2014-12-16
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-08-06
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=131161
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    System, imaging, pulsed echo, ultrasonic - Product Code IYO
  • 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.

Device

Device Recall AxoTrack I Sterile Procedure Kit, 18G (K100118XTW)
  • Model / Serial
    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).
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • 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.
  • Product 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.
  • Manufacturer
    Soma Access Systems LLC

Manufacturer

Soma Access Systems LLC
  • Manufacturer Address
    Soma Access Systems LLC, 109 Laurens Rd Ste 4c, Greenville SC 29607-1860
  • Manufacturer Parent Company (2017)
    Soma Access Systems Llc
  • Source
    USFDA