AngioDynamics VenaCure EVLT NeverTouch-FRS PROCEDURE KIT under the following labeling: 1) Gold-Tipped Fiber 45cm Kit, Ca

FDA device recall Z-1406-2013 · posted 2013-05-25 · Terminated

Recall details

Recalling firm

Angiodynamics, Inc.

Reason for recall

AngioDynamics Inc., is recalling Micro Introducer Kits and VenaCure EVLT NeverTouch Procedure Kits, because the potential exists that the micro Introducer (sheath/dilator) packaged within the kit could be the wrong French size.

Action taken

AngioDynamics sent an Urgent Medical Device Recall letter dated April 29, 2013, to all customers by Fed Ex. The letter identified the affected product, problem and actions to be taken. Customers were instructed to lmmediately remove the affected product from inventory and call AngioDynamics, Inc. Customer Service at 1-800-772-6446 to obtain a replacement or credit for your returned product and to obtain UPS Account Number to return the package via second day delivery. Customers are instructed to segregate and return all affected devices to: AngioDynamics 603 Queensbury Avenue Queensbury, NY 12804 Attn: Micro Introducer and VenaCure EVLT NeverTouch Procedure Kits Recall Coordinator. Write the RMA number on the shipping box (Provied on the Recall Verification Tracking Form). 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 the notification form and the Reply Verification Form. Send the Reply Verification form to AngioDynamics either via Fax or Emai. Fax Reply Verification Tracking Form to: Attn: Micro Introducer and VenaCure EVLT NeverTouch Procedure Kits Recall Coordinatory Fax number 1-518-798-1360 or Email Reply Verification Tracking Form to: rdenino@angiodynamics.com.

Root cause

Labeling mix-ups

Status

Terminated

Product code

GEX

Quantity affected

Domestic Only: 1) 300 units, 2) 300 units, 3) 151 units.

Distribution

USA Nationwide Distribution including the states of: IL, GA, CA, NY OH, AZ, TX, NE, FL, PA, NC, WI, AL, IN, CO, MO, MT, NE, MA, VA, AK, IN, MI, NJ, MD, TN, CT, WA, MN

Date initiated

2013-04-30

Date posted

2013-05-25

Date terminated

2016-11-09

Location

Queensbury, NY

Related 510(k) clearances