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U.S. Department of Health and Human Services

Class 2 Device Recall MRDP50AXS; 5F DIGNITY CT PORT

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  Class 2 Device Recall MRDP50AXS; 5F DIGNITY CT PORT see related information
Date Initiated by Firm January 13, 2021
Date Posted March 08, 2021
Recall Status1 Open3, Classified
Recall Number Z-1184-2021
Recall Event ID 87265
510(K)Number K132177  
Product Classification Port & catheter, implanted, subcutaneous, intravascular - Product Code LJT
Product Power Injectable CT Port insertion kits - Product Usage: is an implantable access device designed to provide repeated access to the vascular system.
Code Information Catalog Number: MRDP50AXS, Lot Number: MPDX180, UDI Number: 884908149753 (updated 3/11/2021 added lot number: MPCY660)
Recalling Firm/
Manufacturer		 Medical Components, Inc dba MedComp
1499 Delp Dr
Harleysville PA 19438-2936
For Additional Information Contact Susan Smith, RN BSN
215-256-4201
Manufacturer Reason
for Recall		 The 5F Dignity CT Port kits were packaged with the incorrect size port. The kits include a 6.6F port instead of the correct 5F port. The inability to connect the catheter lumen to the port stem because of the incorrect size may not be noted until well into the procedure, after the catheter lumen is placed in the vessel. An alternate port will need to be obtained prolonging the procedure. A prolonged insertion procedure increases any risk associated with a surgical procedure.
FDA Determined
Cause 2		 Employee error
Action On 1/13/2021 and 02/10/2021, Medical Components issued an Urgent Medical Device Removal notification to customers via letter notifying customers the 5F Dignity CT Port kits were packaged with the incorrect size port. The kits include a 6.6F port instead of the correct 5F port. (updated 3/11/2021)
Quantity in Commerce 96 pieces total (updated 3/11/2021 additional 72 pieces)
Distribution US Nationwide distribution in the states of CA, DC, GA, IL, IN, MA, MI, NJ, NM, NY, OH, PA, TX. Updated 3/11/2021
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = LJT and Original Applicant = MEDCOMP (MEDICAL COMPONENTS)
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