FDAFDA · Food and drugs·Recall number Z-1406-2013
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.
Published June 5, 2013 · Recall initiated: April 30, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Angiodynamics, Inc.
- Distributor
- 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
- Lot
- Corresponding Lot numbers: 1) 588948, 2) 588495 and 3)588480. Expiration date for these lot numbers: 12/2013.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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