AngioDynamics Angiographic catheter --- Soft-Vu (JB-1) Non-braided. --- Size: 5F; Length: 100cm; designed to accept guid

FDA device recall Z-2180-2012 · posted 2012-08-09 · Terminated

Recall details

Recalling firm

Angiodynamics Worldwide Headquarters

Reason for recall

AngioDynamics is recalling one lot of Soft-Vu Angiographic catheters because one of the catheter pouches within the outer box may be mislabeled.

Action taken

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

Root cause

Labeling mix-ups

Status

Terminated

Product code

DQO

Quantity affected

7 boxes/35 units

Distribution

Worldwide distribution: USA (nationwide) including states of: CA, KS, MO, and NC and countries of: Czech Republic and Switzerland.

Date initiated

2012-06-15

Date posted

2012-08-09

Date terminated

2016-02-10

Location

Latham, NY

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