FDA-Device2013-06-05Class II
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.
Angiodynamics, Inc.
Hazard
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.
Sold states
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
Affected count
Domestic Only: 1) 300 units, 2) 300 units, 3) 151 units.
Manufactured in
603 Queensbury Ave, N/A, Queensbury, NY, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1406-2013Don't want to check this manually?
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