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U.S. Department of Health and Human Services

Class 2 Device Recall 8F Plastic Dignity MidSized CT Port

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 Class 2 Recall
8F Plastic Dignity MidSized CT Port
see related information
Date Posted May 18, 2012
Recall Status1 Terminated on July 18, 2013
Recall Number Z-1626-2012
Recall Event ID 61860
Premarket Notification
510(K) Number
K070003 
Product Classification Port & Catheter, Implanted, Subcutaneous, Intravascular - Product Code LJT
Product 8F Plastic Dignity Mid-Sized CT Port w/Silicone Filled Suture Holes and w/Attachable ChronoFlex Polyurethane Catheter. Catalog # MRCTI8000S. The Power Injectable, Implantable Infusion Port is an implantable single fluid reservoir port with a polyurethane (8F) catheter attachable for application by the inserting physician.
Code Information Lot #MDPZ600 Expiration date 2015/02
Recalling Firm/
Manufacturer
Medical Components, Inc dba MedComp
1499 Delp Dr
Harleysville, Pennsylvania 19438
For Additional Information Contact Susan Smith, RN BSN
215-256-4201 Ext. 225
Manufacturer Reason
for Recall
50 trays of Dignity Low Profile CT Port were labeled as Dignity Mid-Sized CT Port.
FDA Determined
Cause 2
TRAINING: Employee Error
Action On April 12, 2012, MedComp sales representatives and the foreign distributor were notified via e-mail with a "Product Alert" notification. The issue was described and requested actions were provided to recipients.
Quantity in Commerce 50 trays
Distribution Worldwide Distribution - - USA, including the states of CA, NJ, AZ, PA, TN and the country of Spain.
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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