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U.S. Department of Health and Human Services

Class 2 Device Recall SoftVu Angiographic Catheter

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 Class 2 Recall
SoftVu Angiographic Catheter
see related information
Date Posted August 09, 2012
Recall Status1 Open
Recall Number Z-2180-2012
Recall Event ID 62341
Premarket Notification
510(K) Number
K061733 
Product Classification Catheter, Intravascular, Diagnostic - Product Code DQO
Product AngioDynamics Angiographic catheter --- Soft-Vu (JB-1) Non-braided. --- Size: 5F; Length: 100cm; designed to accept guidewire: .035 in. --- Catalog No. [REF]: 10734201. Packaged in boxes of 5 catheters each, with manufacturer listed as AngioDynamics, Inc., Queensbury, NY USA. Intended use: angiographic diagnosis.
Code Information Lot: 564325
Recalling Firm/
Manufacturer
Angiodynamics Worldwide Headquarters
14 Plaza Drive
Latham, New York 12110-3421
For Additional Information Contact Joseph Gersuk
518-795-1111
Manufacturer 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.
FDA Determined
Cause 2
MISBRANDING: Labeling False and Misleading
Action 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.
Quantity in Commerce 7 boxes/35 units
Distribution Worldwide distribution: USA (nationwide) including states of: CA, KS, MO, and NC and countries of: Czech Republic and Switzerland.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = DQO and Original Applicant = ANGIODYNAMICS, INC.
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