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U.S. Department of Health and Human Services

Class 2 Device Recall StarBurst MRI SemiFlex Electrode Device

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  Class 2 Device Recall StarBurst MRI SemiFlex Electrode Device see related information
Date Initiated by Firm December 19, 2014
Date Posted February 24, 2015
Recall Status1 Terminated 3 on November 27, 2015
Recall Number Z-1143-2015
Recall Event ID 70388
510(K)Number K992693  
Product Classification Electrosurgical, cutting & coagulation & accessories - Product Code GEI
Product Starburst MRI Semi-Flex Electrode Device, 25cm/Attached Cable/14Ga/6.4F, Product No. H7877001039091, Catalog No. 700-103909; 25cm/14Ga/6.4F, Product No. H7877001026151, Catalog No. 700-102615; and 25cm/14Ga/6.4F, Product No. H7877001026151, Catalog No. 700-102615
Code Information Lot No. 4773676, 4776428 and 4780110
Recalling Firm/
Manufacturer		 Angiodynamics
10 Technical Park
Glens Falls NY 12804
For Additional Information Contact Michael Duerr
518-742-4571
Manufacturer Reason
for Recall		 Printed mark on the trocar intended to indicate a 5cm distance from the distal tip of the needle is actually located 4cm from the distal tip of the needle.
FDA Determined
Cause 2		 Other
Action AngioDynamics sent an Urgent Medical Device Recall - Immediate Action Required letter dated December 19, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Actions to be taken: Immediately remove the recall product from your inventory (whether in labs, Central Supply, Shipping and Receiving or ANY other location). Segregate this product in a secure location for return to AngioDynamics, Inc. Immediately forward a copy of this recall notification to all sites to which you have distributed affected product. If affected product is located in your institution, please call AngioDynamics, Inc. Customer Service at 1-800-772-6446 between 8:00a.m. and 7:00p.m. (Monday- Friday: Eastern Standard Time) to obtain a replacement or credit for your returned product. Promptly complete, sign and return the enclosed Reply Verification Tracking Form (even if you do not have any product to return) following the directions on this page and the Reply Verification Form.
Quantity in Commerce 43
Distribution Worldwide Distribution - US Distribution to the states of AZ, AR, FL, MI, MN, MO, NY, TX, VA, WA and WI., and to the countries of Hungary and Spain.
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 = GEI and Original Applicant = RITA MEDICAL SYSTEMS
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