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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 Device Recall SoftVu Angiographic Catheter see related information
Date Initiated by Firm June 07, 2011
Date Posted September 16, 2011
Recall Status1 Terminated 3 on October 18, 2012
Recall Number Z-3259-2011
Recall Event ID 59794
510(K)Number K061733  
Product Classification Catheter, intravascular, diagnostic - Product Code DQO
Product ANGIODYNAMICS Angiographic Catheter, Soft-Vu Cobra (2) BRAIDED, 5 F x 90 cm x .035 in., Catalog No./REF 10709105, STERILE, MANUFACTURED IN USA, AngioDynamics, Inc. 603 Queensbury Avenue, Queensbury, NY 12804

Angiographic catheter
Code Information Lot 517631, Use By 06/2013
Recalling Firm/
Manufacturer		 Angiodynamics Worldwide Headquarters
14 Plaza Drive
Latham NY 12110-3421
Manufacturer Reason
for Recall		 The lot of Soft-Vu Catheters was labeled 90 cm in length; however the product was cut to a 65 cm length.
FDA Determined
Cause 2		 Employee error
Action The firm ANGIODYNAMICS, Inc., sent an "URGENT: MEDICAL DEVICE RECALL" letter dated June 7, 2011 to the consignees via Certified Mail, Return Receipt Requested. The letter described the product, problem and action to be taken. The customers were instructed not to use the product and to return it to AngioDynamics, Inc. in Queensbury, NY. The letter also instructed the consignees to (1.) Identify and segregate the recalled lot that is in your possession, (2.) Complete the enclosed Soft-Vu Angiographic Catheter Recall Reply Form and fax it to the attention of the Soft-Vu Angiographic Catheter Recall Coordinator at 518-798-1360. It is important that even if you do not have any product remaining in your possession that you fill out the attached form noting zero quantity to be returned and fax the form to ANGIODYNAMICS. (3.) Ship the recalled product to ANGIODYNAMICS. Replacement product will be shipped upon receipt and confirmation of the returned product. Reference Return Authorization Number XXXXXXXXXX on the outside of the shipping box and include a copy of the Soft-Vu Angiographic Catheter Recall Reply Form with your shipment. 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.
Quantity in Commerce Domestic - 25 units; Foreign - 5 units
Distribution Worldwide distribution: USA (nationwide) including states of: California, Tennessee, and Wisconsin, and country of: Spain.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = DQO and Original Applicant = ANGIODYNAMICS, INC.
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