AngioDynamics VenaCure EVLT NeverTouch Procedure Kit, 45CM NEVERTOUCH FRS .018 PROCEDURE KIT PG, Catalog Number 11403012
FDA Recall Z-2444-2019 · Posted None
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Recalling FirmAngiodynamics, Inc.
Recall StatusTerminated
Product CodeGEX
Date Initiated2019-06-27
Date Terminated2020-07-29
Product Quantity109
Reason for Recall
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.
Firm Action
Customers were contacted via telephone on 6/27/19 directing them to stop using the affected product and segregate until receipt of written Recall Notification. Urgent Voluntary Medical Device Recall notification letters were sent to customers on July 2, 2019.
Root Cause
Under Investigation by firm
Distribution Pattern
The products were distributed to the following US states: DC, IL, IN, MI, NJ, TN, TX, and WI.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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