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U.S. Department of Health and Human Services

Class 2 Device Recall Profiler Balloon Catheter

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  Class 2 Device Recall Profiler Balloon Catheter see related information
Date Initiated by Firm February 25, 2011
Date Posted September 19, 2011
Recall Status1 Terminated 3 on October 18, 2012
Recall Number Z-3261-2011
Recall Event ID 59831
510(K)Number K062609  
Product Classification Percutaneous Catheter - Product Code DQY
Product ANGIODYNAMICS PROFILER BALLOON DILATATION CATHETER, Catalog No./REF 16801101, BALLOON DIAMETER 4MM, BALLOON LENGTH 2 CM, CATHETER LENGTH 40 CM, STERILE, MANUFACTURED IN USA AngioDynamics 603 Queensbury Avenue, Queensbury, NY 12804

Cardiovascular catheterization
Code Information Lot 532109 (Use By 2013-12)
Recalling Firm/
Manufacturer		 Angiodynamics Worldwide Headquarters
14 Plaza Drive
Latham NY 12110-3421
Manufacturer Reason
for Recall		 The particular lots of Profiler PTA Balloon Catheters were labeled incorrectly. Lot 532109 contains product that is actually 5 mm x 4 cm x 40 cm and Lot 532794 contains product that is actually 4 mm x 2 cm x 40 cm.
FDA Determined
Cause 2		 Employee error
Action Angiodynamics, Inc sent a "Urgent Medical Device Recall letter" dated February 25, 2011 to all affected customers via Certified Mail Return Receipt Requested. The letter identified the product the problem and the action needed to be taken by the customer. The customer was instructed the following steps 1. Identify and segregate the recalled lot that is in your possession. 2. Complete the enclosed Profiler PTA Balloon Catheter Recall Reply Form and fax it to the attention of the Profiler PTA Balloon Catheter Recall Coordinator at 518-798-1360. The form lists the catalog numbers, lot numbers, and quantity our records indicate your facility has received. For further questions please call 1-800-772-6446.
Quantity in Commerce 15 units
Distribution Nationwide Distribution including the states of CA, GA, ID, MI, OH and PA.
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 = DQY and Original Applicant = ANGIODYNAMICS, INC.
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