Class 2 Device Recall medCOMP(R) MRCTI66841 6.6F Plastic Dignity Low Profile CT Port with PreAttached Chronflex(R) Polyur

• Date Initiated by Firm: July 02, 2010
• Date Posted: August 17, 2010
• Recall Status: Terminated on October 13, 2010
• Recall Number: Z-2235-2010
• Recall Event ID: 56225
• 510(K)Number: K070003
• Product Classification: Implanted Subcutaneous Intravascular Port & Catheter - Product Code LJT
• Product: medCOMP(R) MRCTI66841 6.6F Plastic Dignity Low Profile CT Port with Pre-Attached Chronoflex(R) Polyurethane Catheter - 1 Unit. Catalog #MRCTI66841.
• Code Information: Lot #MAZL630, Exp. 04/2015
• Recalling Firm/ Manufacturer: Medical Components, Inc dba MedComp; 1499 Delp Dr; Harleysville PA 19438
• For Additional Information Contact: Susan Smith, RN BSN; 215-256-4201 Ext. 225
• Manufacturer Reason for Recall: Recalled product was packaged with the incorrect port and does not match the label. The kit is labeled as a 6.6F "Dignity" Low Profile CT Port. The kit contains a 6.6F "Pro-Fuse" Low Profile CT Port.
• FDA Determined Cause: Employee error
• Action: Medcomp sales reps and foreign distributor were notified via email on 7/1/10. Product is to be returned to Medcomp.
• Quantity in Commerce: 47 units
• Distribution: Worldwide Distribution -- USA, including states of NC and TX and country of Israel.
• 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