Class 2 Device Recall Starburst Talon SemiFlex Electrosurgical Device

• Date Initiated by Firm: October 02, 2019
• Create Date: November 15, 2019
• Recall Status: Terminated on July 29, 2020
• Recall Number: Z-0411-2020
• Recall Event ID: 84072
• 510(K)Number: K010060
• Product Classification: Electrosurgical, cutting & coagulation & accessories - Product Code GEI
• Product: Starburst Talon Semi-Flex Electrosurgical Device, Part Number H7877001028451 incorrectly labelled as Starburst MRI Semi-Flex Electrosurgical Device, Part Number H7877001026151
• Code Information: Lot 5476032
• Recalling Firm/ Manufacturer: Angiodynamics Inc. (Navilyst Medical Inc.); 10 Glens Falls Tech Park; Glens Falls NY 12801-3864
• For Additional Information Contact: David Greer; 518-795-1676
• Manufacturer Reason for Recall: The devices are not labelled correctly. End users impacted by this issue may experience a procedural delay.
• FDA Determined Cause: Under Investigation by firm
• Action: On October 2, 2019, AngioDynamics initiated a recall action by contacting customers by telephone and directing them to stop using the affected product and segregate until receipt of written the written recall notification. URgent Voluntary Medical Device Recall notification letters were sent to these customers on October 8, 2019. 1. Actions to be taken: " IMMEDIATELY o Stop using the product subject to recall. o Remove any affected (recalled) product from your inventory (whether in labs, Central Supply, Shipping and Receiving or ANY other location). o Segregate this product in a secure location for return to AngioDynamics, Inc. o Forward a copy of this recall notification to all sites to which you have distributed affected product. 2. Complete and return the Reply Verification Tracking Form. " If affected product is located in your institution, please call AngioDynamics Customer Service at 1-800- 772-6446 between 8:00 a.m. and 7:00 p.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 Tracking Form. ¿ Email Reply Verification Tracking Form (preferred): recall@angiodynamics.com ¿ Fax Reply Verification Tracking Form: Attn: Talon Semi-Flex Recall Coordinator Fax number 1-800-782-1357 3. Package and Return the Recalled Product. " Package any product that is being returned in an appropriate shipping box. " Write the RMA number on the RMA/Address label (provided on the Recall Verification Tracking Form) and affix the label to the outside of the shipping box. " To request a shipping label for returning product, please contact Customer Service (via recall email address) for a prepaid FedEx label. " Seal the box and return to: AngioDynamics, Inc. 603 Queensbury Avenue Queensbury, NY 12804 Attn: T
• Quantity in Commerce: 30
• Distribution: The products were distributed to the following US states: LA, MA, OR, VA, and WA.
• 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