Retiro De Equipo (Recall) de Device Recall VenaCure EVLT

Recall

60467

Class 2

Z-0401-2012

2011-11-10

2012-01-11

Terminated

United States

2016-02-01

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=105500

During an in-process inspection the hemostasis sidearm assemblies were identified to have the potential for flash to exist on the housing at the base of the threads. this flash has the potential to break off and relocate within the fluid path.

AngioDynamics sent an URGENT: Medical Device Recall letters and response form (dated November 10, 2011) to all affected customers. The letter identified the affected products, the problem, and the actions to be taken by customer/user. The customers were instructed to do the following: 1) Identify, segregate and return the recalled products to ANGIODYNAMICS and 2) Complete the enclosed Recall Reply Form even if they do not have any products remaining in their possession, noting zero quantity to be returned and fax to 518-798-1360. The letter states that a returned authorization number (RA#) will be assigned to each customer in the recall notification letter, an UPS account will be provided for return freight and a replacement product will be shipped upon receipt and confirmation of the returned product. If you have any additional questions or concerns or need more detailed instruction on how to comply with this notice, please do not hesitate to contact your local sales representative or call the Customer Service Manager, at ANGIODYNAMICS Customer Service at 1-800-772-6446. You may also e-mail your questions to customerservice@angiodynamics.com.