Recall Z-0739-2012 ยท GEX Powered Laser Surgical Instrument
Angiodynamics Worldwide Headquarters
VenaCureEVLT Perforator Vein Ablation Kit, CATALOG #: EVLT/PVAK, STERILE -- Manufactured for: AngioDynamics Inc. 603 Queensbury, NY 12804 USA, AngioDynamics UK Limited, Building 2000, Beach Drive, IQ Cambridge, Waterbeach, Cambridge, CB259TE, United Kingdom --- COMMON/USUAL NAME: Laser Surgical Instrument; CLASSIFICATION NAME: Powered Laser Surgical Instrument; DEVICE LISTING # D053485. --- Prod
| Date | Jan 13, 2012 (initiated Dec 6, 2011) |
| Status | Terminated |
| Reason | The product was labeled with a specific indication for the treatment of perforator veins and this specific indication had not received FDA clearance prior to the product being marketed in the US. |
| Root cause | Error in labeling |
| Action | Angiodynamics sent an Urgent Medical Device Recall Letters and Response Forms dated December 2, 2011 to all affected consignees via Certified Mail on December 6, 2011. The recall was extended to the medical user level. The letter identified the product, problem, and actions to be taken. Customers were instructed not to use the product and to return recalled product to AngioDynamics, Inc. in Queensbury, NY. The letter states if the affected product/lot have been distributed, please inform your customers of this recall action immediately and have them return the recalled units. For questio |
| Quantity | 7640 units domestically |
| Distribution | (USA) Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.