Medical Components, Inc dba MedComp: Medical Device Recall in 2017 - (Recall #: Z-1536-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

Product Description:

9.6F Plastic Dignity Mid-Sized CT Port w/Pre-Attached Silicone Catheter The CT Power Injectable Implantable Infusion Ports are indicated for patient therapies requiring repeated access to the vascular system. The port system can be used for infusion of medications, I.V. fluids, parenteral nutrition solutions, blood products, and for the withdrawal of blood samples. When used with a power injectable needle, the Power Injectable Implantable Infusion Port device is indicated for power injection of contrast media

Product Classification:

Class II

Date Initiated: February 23, 2017

Date Posted: March 29, 2017

Recall Number: Z-1536-2017

Event ID: 76625

Reason for Recall:

The 9.6F port kits were packaged with the incorrect valved peelable introducer. The label states the kit contains a 10F valved peelable introducer. The kit is packaged with a 9F valved peelable introducer. The port lumen will not fit through the introducer during the insertion procedure.

Status: Terminated

Product Quantity: 71 units

Code Information:

MRCTI96801 Lot# MHWQ060 S2 , UDI# 884908031232

Distribution Pattern:

Worldwide Distribution to PR and Panama

Voluntary or Mandated:

Voluntary: Firm initiated