Class 2 Device Recall Plastic Dignity Low Profile CT Port

• Date Initiated by Firm: May 25, 2017
• Create Date: February 06, 2018
• Recall Status: Terminated on September 04, 2018
• Recall Number: Z-0533-2018
• Recall Event ID: 78221
• 510(K)Number: K132177
• Product Classification: Port & catheter, implanted, subcutaneous, intravascular - Product Code LJT
• Product: 6.6F Plastic Dignity Low Profile CT Port W/Attachable ChronoFlex Polyurethane Catheter, Catalog # MRCTI66041, UDI#- 884908031157 Product Usage: 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: Lot # MHGB030 Exp. Date 2020-07-30
• Recalling Firm/ Manufacturer: Medical Components, Inc dba MedComp; 1499 Delp Dr; Harleysville PA 19438-2936
• For Additional Information Contact: Susan Smith RN BSN; 215-256-4201
• Manufacturer Reason for Recall: The kit was packaged with the incorrect introducer needle size. The label indicates the kit contains an 18G Needle w/Echo Tip. The kits were packaged with a 21G Needle w/Echo Tip.
• FDA Determined Cause: Mixed-up of materials/components
• Action: On May 25, 2017, Medcomp distributed Product Recall notices to their customers via email. Medcomp requested the return of all un-used affected product. Customers were advised to immediately examine inventory and to quarantine product subject to recall. If product was further distributed, notification of the recall to those individuals is required. Contact your customer service representative for a Returned Goods Authorization (RGA) number if necessary. The request can be made by telephone by calling 215-256-4201.
• Quantity in Commerce: 65 units
• Distribution: Arabia, Australia, Israel, Brunei & Jamaica
• 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