Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Power Injectable CT Port insertion kits - Product Usage: is Recalled by Medical Components, Inc dba MedComp Due to The 5F Dignity CT Port kits were packaged...

Date: January 13, 2021
Company: Medical Components, Inc dba MedComp
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Medical Components, Inc dba MedComp directly.

Affected Products

Power Injectable CT Port insertion kits - Product Usage: is an implantable access device designed to provide repeated access to the vascular system.

Quantity: 96 pieces total (updated 3/11/2021 additional 72 pieces)

Why Was This Recalled?

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.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Medical Components, Inc dba MedComp

Medical Components, Inc dba MedComp has 38 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report