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U.S. Department of Health and Human Services

Class 2 Device Recall MedComp 8F Plastic ProFuse(R) CT Low Profile Port with Attachable Chronoflex(R) Polyurethane Cathet

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  Class 2 Device Recall MedComp 8F Plastic ProFuse(R) CT Low Profile Port with Attachable Chronoflex(R) Polyurethane Cathet see related information
Date Initiated by Firm April 02, 2012
Date Posted June 26, 2012
Recall Status1 Terminated 3 on May 20, 2013
Recall Number Z-1868-2012
Recall Event ID 62238
510(K)Number K070003  
Product Classification Port & catheter, implanted, subcutaneous, intravascular - Product Code LJT
Product MRCTT80041 MedComp 8F Plastic Pro-Fuse(R) CT Low Profile Port with Attachable Chronoflex(R) Polyurethane Catheter.

Power Injectable Implantable Infusion Port insertion kit.
Code Information Catalog number MRCTT80041, Lot # MDNK860, Exp 02/2015
Recalling Firm/
Medical Components, Inc dba MedComp
1499 Delp Dr
Harleysville PA 19438
For Additional Information Contact
Manufacturer Reason
for Recall
Product was packaged with the incorrect port and does not match the label. The kit is labeled as an 8F Low Profile Pro-Fuse CT Port. The kit contains an 8F Midsize Dignity CT Port.
FDA Determined
Cause 2
Packaging process control
Action MedComp sent a "PRODUCT ALERT" letter dated April 2, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The firm requested the return of all affected product. Contact the firm at 215-256-4201 ext. 2225 for questions regarding this notice.
Quantity in Commerce 30
Distribution Worldwide Distribution-USA (nationwide) including the states of GA and WA and the countries of Ireland and Turkey.
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