FDAClass IIJune 5, 2013

AngioDynamics VenaCure EVLT NeverTouch-FRS PROCEDURE recall

AngioDynamics VenaCure EVLT NeverTouch-FRS PROCEDURE KIT under the following labeling: 1) Gold-Tipped Fiber 45cm Kit, Catalog Number: 11403301; 2)…

Why was AngioDynamics VenaCure EVLT NeverTouch-FRS PROCEDURE recalled?

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 should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Corresponding Lot numbers: 1) 588948, 2) 588495 and 3)588480. Expiration date for these lot numbers: 12/2013.

Product
AngioDynamics VenaCure EVLT NeverTouch-FRS PROCEDURE KIT under the following labeling: 1) Gold-Tipped Fiber 45cm Kit, Catalog Number: 11403301; 2)…
Recalling firm
Angiodynamics, Inc.
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
Recall date
June 5, 2013
Classification
Class II
Status
Terminated
Agency
FDA (device)
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