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U.S. Department of Health and Human Services

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

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  Class 2 Device Recall medCOMP(R) MRCTI66841 6.6F Plastic Dignity Low Profile CT Port with PreAttached Chronflex(R) Polyur see related information
Date Initiated by Firm July 02, 2010
Date Posted August 17, 2010
Recall Status1 Terminated 3 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 2		 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 and Original Applicant = MEDCOMP
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