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U.S. Department of Health and Human Services

Class 2 Device Recall AngioDynamics SmartPort

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  Class 2 Device Recall AngioDynamics SmartPort see related information
Date Initiated by Firm July 16, 2009
Date Posted September 01, 2009
Recall Status1 Terminated 3 on October 27, 2010
Recall Number Z-1898-2009
Recall Event ID 52762
510(K)Number K081472  
Product Classification Port & catheter, implanted, subcutaneous, intravascular - Product Code LJT
Product SmartPort CT Port Access System, Catalog number CT80STPD, AngioDynamics Incorporated

The SmartPort CT Port Access System is indicated for any patient requiring repeated access of the vascular system or other selected body site, for delivery of medications, nutritional supplementation, fluids, blood products, and sampling of blood.
Code Information Lot number: 983533
Recalling Firm/
Angiodynamics, INC
1 Horizon Way
Manchester GA 31816-1749
For Additional Information Contact David Derrick
Manufacturer Reason
for Recall
The product may contain an incorrect size catheter and introducer.
FDA Determined
Cause 2
Packaging process control
Action Notification of the AngioDynamics, Inc. sales force began on July 16, 2009 and they were asked to assist in the return of all affected devices to the Manchester, GA division of AngioDynamics, Inc. Urgent Recall letters were sent to all customers on July 16, 2009, requesting the completion of a FAX BACK form. Those currently in possession of any remaining devices will be provided a Return Goods Authorization (RGA) number and pre-paid shipping boxes for return of the product to AngioDynamics, Inc. All returned devices will be physically and electronically quarantined until final disposition of the devices. All devices will be inspected for damage to the devices and any damaged devices destroyed (scrapped) via the AngioDynamics procedure for Disposition of Nonconformances, procedure. Non-damaged product may be reworked to remove the incorrect catheter and introducer and replaced with the correct catheter and introducer, repackaged and re-sterilized in accordance with the AngioDynamics procedure for Rework. If necessary, follow-up letters, phone calls or visits by the AngioDynamics sales representatives may be used to complete the effective checks. Level A (100%) of consignees to be contacted). Please contact your local representative or Recall Coordinator at 1-706-846-3126, for assistance. You may e-mail your questions to customerservice@angiodynamics.com.
Quantity in Commerce 150 kits
Distribution AL, CA, CO, FL, GA, ID, IL, IN, KS, LA, MI, MO, MN, MS, NC, NY, OH, OR, PA, TN and TX.
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 = LJT and Original Applicant = ANGIODYNAMICS, INC.