Z-2444-2019 Class II Terminated
FDA device recall Z-2444-2019 was initiated by Angiodynamics, Inc. on June 27, 2019 and is designated Class II. 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… The recall status is terminated (terminated July 29, 2020). Affected quantity: 109.
Recall Details
- Product Type
- Devices
- Report Date
- September 11, 2019
- Initiation Date
- June 27, 2019
- Termination Date
- July 29, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 109
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.
Distribution Pattern
The products were distributed to the following US states: DC, IL, IN, MI, NJ, TN, TX, and WI.
Code Information
Lot 5456490; UPN H787114030120