Recall Z-1819-2022 ยท GEX Powered Laser Surgical Instrument
Angiodynamics, Inc.
VenaCure EVLT KIT WITH SPOTLIGHT OPS SHEATH 55CM Ref./ Catalog No.: EVLT55OPS (each box contains 5 Procedure Kits). For use in the treatment of varicose veins.
| Date | Sep 27, 2022 (initiated Aug 10, 2022) |
| Status | Open, Classified |
| Reason | OPS Fiber packaged within specific VenaCure EVLT Procedure Kits does not meet the required dimensional specification, may result in damage to the sheath, including separation or the inability to move the fiber within the sheath. A damaged sheath will necessitate removal from the patient, which may result in procedural delay and/or surgical intervention |
| Root cause | Under Investigation by firm |
| Action | AngioDynamics, Inc, issued Urgent Voluntary Medical Device Recall letter dated 8/10/22 via Federal Express states reason for recall, health risk and action to take: 1. Actions to be taken: IMMEDIATELY o Stop using the product subject to recall. o Remove any affected (recalled) product from your inventory (whether in labs, Central Supply, Shipping and Receiving or ANY other location). o Segregate this product in a secure location for return to AngioDynamics, Inc. o Forward a copy of this recall notification to all sites to which you have distributed affected product. 2. Complete and return th |
| Quantity | 40 units |
| Distribution | US Nationwide distribution in the states of FL, NC, NJ, NM, NY, PA, TX, VA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K041957 | EVLT KIT AND THE D15PLUS AND D30PLUS DIODE LASERS Diomed, Inc., Dec 1, 2004 |