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U.S. Department of Health and Human Services

Class 2 Device Recall Vortex TR

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  Class 2 Device Recall Vortex TR see related information
Date Initiated by Firm September 27, 2010
Date Posted November 17, 2010
Recall Status1 Terminated 3 on June 21, 2011
Recall Number Z-0403-2011
Recall Event ID 56876
510(K)Number K032557  
Product Classification Pump, infusion - Product Code FRN
Product Vortex TR, AngioDynamics, Inc., One Horizon Way, Manchester, GA 31816
Code Information Catalogue Number: SPDX-14-1, SPAX-16-1, SSDX-10-1, SSAX-14-1, SSAX-16-1, SSDX-16-1, PSAX-10-1, PSDX-10-1, SPDX-16-1 and SSDX-14-1.
Recalling Firm/
Manufacturer		 Angiodynamics, INC
1 Horizon Way
Manchester GA 31816-1749
For Additional Information Contact David Derrick
706-846-3126 Ext. 3114
Manufacturer Reason
for Recall		 Labeling Error; The labeling for the specific products incorrectly identified that the packaged device kit contains a Lifeguard Safety Infusion Set.
FDA Determined
Cause 2		 Other
Action AngioDynamics issued a Notification of Medical Device Correction letter dated September 27, 2010 to customers. The notification served to make the customer aware of the mislabeling. Customers were instructed not to return the affected products. Customers can contact AngioDynamics at 1 800 772-6446 about this correction.
Quantity in Commerce see line one.
Distribution Nationwide Distribution : Throughout the US.
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 = FRN and Original Applicant = HORIZON MEDICAL PRODUCTS, INC.
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