Class 2 Device Recall AngioDynamics Micro Introducer Kits

• Date Initiated by Firm: April 30, 2013
• Date Posted: May 25, 2013
• Recall Status: Terminated on November 09, 2016
• Recall Number: Z-1405-2013
• Recall Event ID: 65119
• 510(K)Number: K051655
• Product Classification: Cannula, catheter - Product Code DQR
• Product: AngioDynamics Micro Introducer Kits under the following labeling: ; 1) AngioDynamics 4F Standard Micro-Introducer Kit, Sterile, Catalog Number: 06597005, 2) AngioDynamics 5F Standard Micro-Introducer Kit, Sterile, Catalog number: 06597012; 3) AngioDynamics 4F Standard Micro-Introducer Kit, Sterile, Catalog Number: 06597013; 4) AngioDynamics 5F Standard Micro- Introducer Kit, Sterile, Catalog Number: 06597018; and 5) AngioDynamics 4F Standard Micro-Introducer Kit, Sterile, Catalog Number: 06597019. Product kits are individually wrapped in plastic, 10 units included per box.; ; Product Usage:; This device is intended to be used to measure the refractive power and the radius of corneal curvature of the human eye.
• Code Information: Corresponding Lot numbers: 1) 588918 (Expiration date 01/2016), 2) 588927 (Expiration date 12/2015), 3) 588915 (Expiration date 01/2016), 4) 588913 (Expiration date 12/2015) and 5) 588930 (Expiration date 01/2016).
• Recalling Firm/ Manufacturer: Angiodynamics, Inc.; 603 Queensbury Ave; Queensbury NY 12804-7619
• For Additional Information Contact: Mark Frost; 518-795-1111
• Manufacturer 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 incorrect French size.
• FDA Determined Cause: Labeling mix-ups
• Action: 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.
• Quantity in Commerce: Domestic(1,760 units): 1)260 units/26 boxes, 2)310 units/31 boxes,3)260 units/26 boxes,4)880 units/88 boxes,5)60 units/6 boxes,Foreign:10 units/1 box
• 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
• 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 = DQR and Original Applicant = ANGIODYNAMICS, INC.