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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 Portsee related information
Date Initiated by FirmNovember 22, 2017
Create DateMarch 29, 2018
Recall Status1 Terminated 3 on July 11, 2018
Recall NumberZ-1271-2018
Recall Event ID 79445
510(K)NumberK132177 
Product Classification Port & catheter, implanted, subcutaneous, intravascular - Product Code LJT
Product8F 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
FEI Number 2518902
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
ActionRecall 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 Commerce24 Eaches
DistributionCA, AR. AL
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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