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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.

FDA Recall Z-0215-2015 · Posted 2014-12-16

Recalling FirmSoma Access Systems LLC
Recall StatusTerminated
Product CodeIYO
Date Initiated2014-03-24
Date Terminated2015-08-06
Product Quantity3530 units

Reason for Recall

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

Firm Action

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

Root Cause

Packaging

Distribution Pattern

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K113680SOMA ACCESS SYSTEMS EXACTTRACK PROCEDURE KITSoma Access Systems, LLC · 2011-12-29

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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