Angiodynamics Inc. (Navilyst Medical Inc.) Starburst Talon Semi-Flex Electrosurgical Device, Part Number H7877001028451 incorrectly labelled as Starburst MRI Semi-Flex Electrosurgical Device, Part Number H7877001026151 Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

The devices are not labelled correctly. End users impacted by this issue may experience a procedural delay.

Recommended Action

Per FDA guidance

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

Distribution

As reported by FDA

LA, MA, OR, VA, WA