VenaCureEVLT Perforator Vein Ablation Kit, CATALOG #: EVLT/PVAK, STERILE -- Manufactured for: AngioDynamics Inc. 603 Que

FDA device recall Z-0739-2012 · posted 2012-01-13 · Terminated

Recall details

Recalling firm

Angiodynamics Worldwide Headquarters

Reason for recall

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.

Action taken

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 questions or concerns call the Customer Service Manager at ANGIODYNAMICS Customer Service at 1-800-722-6446.

Root cause

Error in labeling

Status

Terminated

Product code

GEX

Quantity affected

7640 units domestically

Distribution

(USA) Nationwide Distribution

Date initiated

2011-12-06

Date posted

2012-01-13

Date terminated

2016-02-05

Location

Latham, NY