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U.S. Department of Health and Human Services

Class 2 Device Recall AxoTrack I Sterile Procedure Kit, 18G (K100118XTW)

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  Class 2 Device Recall AxoTrack I Sterile Procedure Kit, 18G (K100118XTW) see related information
Date Initiated by Firm March 24, 2014
Date Posted December 16, 2014
Recall Status1 Terminated 3 on August 06, 2015
Recall Number Z-0215-2015
Recall Event ID 69619
510(K)Number K113680  
Product Classification System, imaging, pulsed echo, ultrasonic - Product Code IYO
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.
Code Information 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). 
Recalling Firm/
Manufacturer		 Soma Access Systems LLC
109 Laurens Rd Ste 4c
Greenville SC 29607-1860
For Additional Information Contact Genoa Atwood
864-752-0087
Manufacturer Reason
for Recall		 There is a possibility the sterile packaging may fail before the expiration date specified on the package.
FDA Determined
Cause 2		 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = IYO and Original Applicant = SOMA ACCESS SYSTEMS LLC
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