Recall Z-2444-2019— Angiodynamics, Inc.
Class II · Terminated
Class II FDA medical device recall by Angiodynamics, Inc., initiated 2019-06-27, terminated 2020-07-29. It names one FDA 510(k) clearance: K112600. Product: AngioDynamics VenaCure EVLT NeverTouch Procedure Kit, 45CM NEVERTOUCH FRS .018 PROCEDURE KIT PG, Catalog Number 11403012. 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..
- Recalling firm
- Angiodynamics, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2019-06-27
- Terminated
- 2020-07-29
- Firm location
- Queensbury, NY, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
AngioDynamics VenaCure EVLT NeverTouch Procedure Kit, 45CM NEVERTOUCH FRS .018 PROCEDURE KIT PG, Catalog Number 11403012
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.