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U.S. Department of Health and Human Services

Class 2 Device Recall AngioDynamics VenaCure EVLT Procedure Kits

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 Class 2 Recall
AngioDynamics VenaCure EVLT Procedure Kits
see related information
Date Posted May 25, 2013
Recall Status1 Open
Recall Number Z-1406-2013
Recall Event ID 65119
Premarket Notification
510(K) Number
K102796 
Product Classification Powered Laser Surgical Instrument - Product Code GEX
Product AngioDynamics VenaCure EVLT NeverTouch-FRS PROCEDURE KIT under the following labeling: 1) Gold-Tipped Fiber 45cm Kit, Catalog Number: 11403301; 2) Gold-Tipped Fiber 65cm Kit, Catalog Number: 11403302; 3) Gold-Tipped Fiber 90cm Kit, Catalog Number: 11403304. 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) 588948, 2) 588495 and 3)588480. Expiration date for these lot numbers: 12/2013.
Recalling Firm/
Manufacturer
Angiodynamics, Inc.
603 Queensbury Ave
Queensbury, New York 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 wrong French size.
FDA Determined
Cause 2
PRODUCTION CONTROLS: 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 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
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = GEX and Original Applicant = ANGIODYNAMICS, INC.
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