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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 Recall
medCOMP(R) MRCTI66841 6.6F Plastic Dignity Low Profile CT Port with PreAttached Chronflex(R) Polyur
see related information
Date Posted August 17, 2010
Recall Status1 Terminated on October 13, 2010
Recall Number Z-2235-2010
Recall Event ID 56225
Premarket Notification
510(K) Number
K070003 
Product Classification Port & Catheter, Implanted, Subcutaneous, Intravascular - 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, Pennsylvania 19438
Consumer Instructions Contact the recalling firm for information
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
TRAINING: 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 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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