Recall Z-1406-2013 ยท GEX Powered Laser Surgical Instrument
Angiodynamics, Inc.
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.
| Date | May 25, 2013 (initiated Apr 30, 2013) |
| Status | Terminated |
| Reason | 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. |
| Root 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 |
| Quantity | 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K102796 | ANGIODYNAMICS, INC. VENACURE PROCEDURE KIT AngioDynamics, Inc., Dec 15, 2010 |