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U.S. Department of Health and Human Services

Class 2 Device Recall 8F Plastic Dignity Low Profile CT Port

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  Class 2 Device Recall 8F Plastic Dignity Low Profile CT Port see related information
Date Initiated by Firm November 22, 2017
Create Date March 29, 2018
Recall Status1 Terminated 3 on July 11, 2018
Recall Number Z-1271-2018
Recall Event ID 79445
510(K)Number K132177  
Product Classification Port & catheter, implanted, subcutaneous, intravascular - Product Code LJT
Product 8F Plastic Dignity¿ Low Profile CT Port W/Pre-Attached ChronoFlex¿ Polyurethane Catheter
Code Information Lot/Serial/Model/Catalog Numbers/Exp. Date:  Lot # MJKK420;  serial # N/A,  Catalog # MRDP80PLN,  Exp. Date 2022-01-09;  UDI#- 884908110449
Recalling Firm/
Manufacturer		 Medical Components, Inc dba MedComp
1499 Delp Dr
Harleysville PA 19438-2936
For Additional Information Contact
215-256-4201
Manufacturer Reason
for Recall		 The kit was packaged with the incorrect guidewire. The label indicates the kit contains a marked guidewire. The kits were packaged with an unmarked guidewire.
FDA Determined
Cause 2		 Mixed-up of materials/components
Action Recall notification was issued, by mail to the customers on November 22, 2017. This notification requested that customers review inventory and return all un-used affected product after quarantine. Questions or concerns can be directed to 215-256-4201/
Quantity in Commerce 24 Eaches
Distribution CA, AR. AL
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 (MEDICAL COMPONENTS)
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