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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 Cathetsee related information
Date Initiated by FirmApril 02, 2012
Date PostedJune 26, 2012
Recall Status1 Terminated 3 on May 20, 2013
Recall NumberZ-1868-2012
Recall Event ID 62238
510(K)NumberK070003 
Product Classification Port & catheter, implanted, subcutaneous, intravascular - Product Code LJT
ProductMRCTT80041 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/
Manufacturer		 Medical Components, Inc dba MedComp
1499 Delp Dr
Harleysville PA 19438
For Additional Information Contact
215-256-4201
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
ActionMedComp 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 Commerce30
DistributionWorldwide Distribution-USA (nationwide) including the states of GA and WA and the countries of Ireland and Turkey.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = LJT
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