FDAClass IISeptember 11, 2019

AngioDynamics VenaCure EVLT NeverTouch Procedure Kit recall

AngioDynamics VenaCure EVLT NeverTouch Procedure Kit, 45CM NEVERTOUCH FRS .018 PROCEDURE KIT PG, Catalog Number 11403012

Why was AngioDynamics VenaCure EVLT NeverTouch Procedure Kit recalled?

The affected product is properly labelled with an expiration date of March 31, 2022; but the RFID programmed expiration date is April-2014 which results in an error message when connected to the laser source and prevents the product from being used.

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?

Lot 5456490; UPN H787114030120

Product
AngioDynamics VenaCure EVLT NeverTouch Procedure Kit, 45CM NEVERTOUCH FRS .018 PROCEDURE KIT PG, Catalog Number 11403012
Recalling firm
Angiodynamics, Inc.
Quantity
109
Distribution
The products were distributed to the following US states: DC, IL, IN, MI, NJ, TN, TX, and WI.
Recall date
September 11, 2019
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls