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U.S. Department of Health and Human Services

Class 2 Device Recall 8F Smart Port CT.

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  Class 2 Device Recall 8F Smart Port CT. see related information
Date Initiated by Firm August 01, 2011
Date Posted October 13, 2011
Recall Status1 Terminated 3 on March 07, 2012
Recall Number Z-0056-2012
Recall Event ID 59526
510(K)Number K062414  
Product Classification Implantable Port - Product Code DYB
Product 8F Smart Port CT, Catalog number: CT80STPD and CT80STPD-NF;
AngioDynamics, INC.

The Smart Port CT Implantable Port is a Single Titanium Port System with Attachable 8.0 Fr. Polyurethane Catheters and 8Fr. Introducer Kit.
Code Information Catalog number: CT80STPD and CT80STPD-NF
Recalling Firm/
Manufacturer		 Angiodynamics, INC
1 Horizon Way
Manchester GA 31816-1749
For Additional Information Contact S. Michael Sharp, PhD
518-795-1123
Manufacturer Reason
for Recall		 The product may contain an incorrect size catheter and introducer.
FDA Determined
Cause 2		 Device Design
Action AngioDynamics, Inc contacted affected customers initially via telephone and a follow up "Notification of Medical Device Correction" letter was sent dated August 1, 2011. The letter informed them of the problem and provided instructions. Customers were instructed to utilize the 8F Introducer Sheath provided within the 8F Smart Port CT Implantable Port during port implantation. The 8F Valved Sheath (V18) may continue to be utilized during the placement of the 7.5F Smart Port Implantable Port (for example: CT75STSD; CT75STSD-NF). For question on this recall contact AngioDynamics, Inc at (800) 772-6446.
Quantity in Commerce 1095 total units
Distribution (USA) Nationwide distribution including the states of CA, FL, GA, IA, IL, IN, KY, MD, MI, MO, NC, NE, NJ, NY, OH, OK, OR, TN, UT, WA and WI.
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 = DYB and Original Applicant = RITA MEDICAL SYSTEMS, INC.
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