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U.S. Department of Health and Human Services

Class 2 Device Recall AngioDynamics SmartPort

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 Class 2 Recall
AngioDynamics SmartPort
see related information
Date Posted September 01, 2009
Recall Status1 Terminated on October 27, 2010
Recall Number Z-1898-2009
Recall Event ID 52762
Premarket Notification
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/
Manufacturer
Angiodynamics, INC
1 Horizon Way
Manchester, Georgia 31816-1749
For Additional Information Contact David Derrick
706-846-3126
Manufacturer Reason
for Recall
The product may contain an incorrect size catheter and introducer.
FDA Determined
Cause 2
PRODUCTION CONTROLS: 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 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 = LJT and Original Applicant = ANGIODYNAMICS, INC.
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