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U.S. Department of Health and Human Services

Class 2 Device Recall Smart Port CT

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  Class 2 Device Recall Smart Port CT see related information
Date Initiated by Firm February 22, 2021
Create Date April 21, 2021
Recall Status1 Terminated 3 on July 19, 2022
Recall Number Z-1466-2021
Recall Event ID 87567
510(K)Number K062414  
Product Classification Port & catheter, implanted, subcutaneous, intravascular - Product Code LJT
Product Smart Port CT-Implantable Port Catalogue #: CT96STSD-VI, CT96STSA-VI - Product Usage: indicated for any patient requiring repeated access of the vascular system, for delivery of medications, nutritional supplementation, fluids, blood, blood products, and sampling of blood and power injection of contrast media for imaging.
Code Information UPN: H787CT96STSDVI1, Lot #: 5616651, 5647359, 5654135 UPN: H787CT96STSAVI1, Lot #: 5654129
Recalling Firm/
Manufacturer		 Angiodynamics Inc. (Navilyst Medical Inc.)
10 Glens Falls Tech Park
Glens Falls NY 12801-3864
For Additional Information Contact David Greer
518-795-1676
Manufacturer Reason
for Recall		 AngioDynamics, Inc. is recalling a specific batch of AngioDynamics Implantable Infusion Port kits and Valved introducers that may have potential for compromised sterility of the device. Only the specific product/lot of the kit identified below is affected by this recall action. The Product Description, Product Number, Ref./Catalog Number and Batch/Lot number is provided below. No other products are affected by this recall.
FDA Determined
Cause 2		 Under Investigation by firm
Action On 2/22/2021, AngioDynamics issued an Urgent Medical Device Recall notice via letter informing customers the package integrity of specific Valved Introducers may be susceptible to failure, resulting in the potential for compromised sterility of the device.
Quantity in Commerce 267 kits
Distribution US Nationwide distribution in the states of AR, CA, CO, FL, HI, IL, IN, KS, MI, MO, NC, ND, NM, NY, OH, OR, PA, SC, TN, TX, VA, WA.
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 = RITA MEDICAL SYSTEMS, INC.
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