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U.S. Department of Health and Human Services

Class 2 Device Recall 9.6F Plastic Dignity MidSized CT port w/PreAttached Silicone Catheter

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  Class 2 Device Recall 9.6F Plastic Dignity MidSized CT port w/PreAttached Silicone Catheter see related information
Date Initiated by Firm February 23, 2017
Date Posted March 08, 2017
Recall Status1 Terminated 3 on February 02, 2018
Recall Number Z-1536-2017
Recall Event ID 76625
510(K)Number K132177  
Product Classification Port & catheter, implanted, subcutaneous, intravascular - Product Code LJT
Product 9.6F Plastic Dignity Mid-Sized CT Port w/Pre-Attached Silicone Catheter
The CT Power Injectable Implantable Infusion Ports are indicated for patient therapies requiring repeated access to the vascular system. The port system can be used for infusion of medications, I.V. fluids, parenteral nutrition solutions, blood products, and for the withdrawal of blood samples. When used with a power injectable needle, the Power Injectable Implantable Infusion Port device is indicated for power injection of contrast media
Code Information MRCTI96801 Lot# MHWQ060 S2 , UDI# 884908031232
Recalling Firm/
Manufacturer		 Medical Components, Inc dba MedComp
1499 Delp Dr
Harleysville PA 19438-2936
For Additional Information Contact Susan M. Smith
215-256-4201
Manufacturer Reason
for Recall		 The 9.6F port kits were packaged with the incorrect valved peelable introducer. The label states the kit contains a 10F valved peelable introducer. The kit is packaged with a 9F valved peelable introducer. The port lumen will not fit through the introducer during the insertion procedure.
FDA Determined
Cause 2		 Unknown/Undetermined by firm
Action Medcomp mailed a Customer Notification letter dated February 23, 2017, to all affected customers to inform them of the issue. Customers were asked to examine their inventory and return all unused product. Distributors were also asked to locate the end user/facility of where the affected product was sold and communicate the recall to them. Customers were instructed to contact their customer service representative for a Returned Goods Authorization (RGA) number if necessary at 215-256-4201. Customers were also instructed to complete and return page 2 of the letter by fax to 215-256-9191. For questions regarding this recall call 215-256-4201.
Quantity in Commerce 71 units
Distribution Worldwide Distribution to PR and Panama
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 = MEDCOMP (MEDICAL COMPONENTS)
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