Z-0215-2015Class II

AxoTrack I Sterile Procedure Kit 18G, K1001-18XTW, (24/case labeled for US, 5/case labeled for US, 24/case...

Name: Z-0215-2015 AxoTrack I Sterile Procedure Kit 18G, K1001-18XTW, (24/case labeled for US, 5/case labeled for US, 24/case...
Creator: Soma Access Systems LLC
Published: 2014-03-24
License: https://open.fda.gov/license/

Innovatus Imaging Corporation / initiated 2014-03-24 / Terminated / root cause: packaging

FDA source

Soma Access Systems LLC began a recall of 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... on 2014-03-24. FDA classified it as Class II and gives the reason as "There is a possibility the sterile packaging may fail before the expiration date specified on the package". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0215-2015
Classification: Class II
Status: Terminated
Initiated: 2014-03-24
Posted: 2014-12-16
Terminated: 2015-08-06
Recalling firm: Innovatus Imaging Corporation
Product: 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.
Product code: IYO System, Imaging, Pulsed Echo, Ultrasonic
Reason for recall: There is a possibility the sterile packaging may fail before the expiration date specified on the package.
Root cause tag: packaging
FDA root cause: Packaging
Action: Consignees were notified via USPS Certified Letter, email and FedEx on 3/24/2014.
Quantity in commerce: 3530 units
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 codes and lots: 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).

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0215-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0215-2015	Class II	Terminated	Voluntary: Firm initiated	2014-11-26	2014-11-14

Product code IYO

K113680Class IISoma Access Systems Exacttrack Procedure KitSoma Access Systems, LLC / cleared 2011-12-29

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)