Recall Z-0215-2015— Soma Access Systems LLC

Name: FDA recall Z-0215-2015
Creator: U.S. Food and Drug Administration
Published: 2014-03-24

Class II · Terminated

Class II FDA medical device recall by Soma Access Systems LLC, initiated 2014-03-24, terminated 2015-08-06. It names one FDA 510(k) clearance: K113680. 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.. Reason: There is a possibility the sterile packaging may fail before the expiration date specified on the package..

Recalling firm: Soma Access Systems LLC
Classification: Class II
Status: Terminated
Initiated: 2014-03-24
Terminated: 2015-08-06
Firm location: Greenville, SC, United States

510(k) clearances named in this recall

1 on FDA's record

K113680 — SOMA ACCESS SYSTEMS EXACTTRACK PROCEDURE KITSoma Access Systems, LLC·cleared 2011-12-29

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.