Class 2 Device Recall MRDP50AXS; 5F DIGNITY CT PORT

• Date Initiated by Firm: January 13, 2021
• Date Posted: March 08, 2021
• Recall Status: Open, 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)
• FEI Number: 2518902
• 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: 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