Device Recall SoftVu Angiographic Catheter 의 리콜

Recall

62341

Class 2

Z-2180-2012

2012-06-15

2012-08-09

Terminated

United States

2016-02-10

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=110292

Angiodynamics is recalling one lot of soft-vu angiographic catheters because one of the catheter pouches within the outer box may be mislabeled.

The firm, AngioDynamics, Inc., sent an "Urgent Medical Device Recall - Immediate Action Required letter dated June 15, 2012 to all consignees/customers via FedEx. The letter described the product, problem and actions to be taken. The consignees/customers were instructed to carefully read this recall notification in its entirety; IMMEDIATELY DISCONTINUE USE OF AND SEGREGATE RECALLED PRODUCT in a secure location for return to AngioDynamics, Inc.; immediately remove recalled product from their inventory; immediately forward a copy of this recall notification to all sites to which they have distributed affected product; and promptly complete, sign and return the Reply Verification Tracking Form (even if you do not have any product to return) via fax to Soft-Vu Angiographic Catheter Recall Coordinator at 1-518-798-1360 or email rdenino@agniodynamics.com. If affected product is located in your institution, please call AngioDynamics, Inc. Customer Service at 1-800-772-6446 between 8:00 a.m. and 7:00 p.m. (Monday - Friday: Eastern Standard Time) to obtain a replacement. The consignees/customers were also instructed to package and return the recalled product, write the RMA number on the box and send to AngioDynamics, Inc., 603 Queensbury Avenue, Queensbury, NY 12804; Attn: Soft-Vu Angiographic Catheter Recall Coordinator. If you have any questions about this recall action, contact your local Sales Representative or AngioDynamics, Inc. Customer Service Manager at 800-772-6446 or by email at customerservice@angiodynamics.com