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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 Recall
Profiler Balloon Catheter
see related information
Date Posted September 19, 2011
Recall Status1 Terminated on October 18, 2012
Recall Number Z-3262-2011
Recall Event ID 59831
Premarket Notification
510(K) Number
K062609 
Product Classification Catheter, Percutaneous - Product Code DQY
Product ANGIODYNAMICS PROFILER BALLOON DILATATION CATHETER, Catalog No./REF 16801105, BALLOON DIAMETER 5MM, BALLOON LENGTH 4 CM, CATHETER LENGTH 40 CM, STERILE, MANUFACTURED IN USA AngioDynamics 603 Queensbury Avenue, Queensbury, NY 12804 Cardiovascular catheterization
Code Information Lot 532794 (Use By 2013-12)
Recalling Firm/
Manufacturer
Angiodynamics Worldwide Headquarters
14 Plaza Drive
Latham, New York 12110-3421
Consumer Instructions Contact the recalling firm for information
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
TRAINING: 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 14 units
Distribution Nationwide Distribution including the states of CA, GA, ID, MI, OH and PA.
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 = DQY and Original Applicant = ANGIODYNAMICS, INC.
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