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Recall Observatory FDA recall evidence

Device product

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

Z-2444-2019

June 27, 2019

Class II

Product summary

Firm
Angiodynamics, Inc.
Event
Event 83334
Status
Terminated
Classification
Class II
Quantity
109
Official record key
device-enforcement:Z-2444-2019

Official wording

Reason: 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.

Code information: Lot 5456490; UPN H787114030120

Distribution pattern: The products were distributed to the following US states: DC, IL, IN, MI, NJ, TN, TX, and WI.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.