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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 Recall
MedComp 8F Plastic ProFuse(R) CT Low Profile Port with Attachable Chronoflex(R) Polyurethane Cathet
see related information
Date Posted June 26, 2012
Recall Status1 Terminated on May 20, 2013
Recall Number Z-1868-2012
Recall Event ID 62238
Premarket Notification
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/
Manufacturer
Medical Components, Inc dba MedComp
1499 Delp Dr
Harleysville, Pennsylvania 19438
Consumer Instructions Contact the recalling firm for information
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
PRODUCTION CONTROLS: 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = LJT and Original Applicant = MEDCOMP
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