Recall Z-0215-2015 ยท IYO System, Imaging, Pulsed Echo, Ultrasonic
Soma Access Systems LLC
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.
| Date | Dec 16, 2014 (initiated Mar 24, 2014) |
| Status | Terminated |
| Reason | There is a possibility the sterile packaging may fail before the expiration date specified on the package. |
| Root cause | Packaging |
| Action | Consignees were notified via USPS Certified Letter, email and FedEx on 3/24/2014. |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K113680 | SOMA ACCESS SYSTEMS EXACTTRACK PROCEDURE KIT Soma Access Systems, LLC, Dec 29, 2011 |