Medical Components, Inc dba MedComp: Medical Device Recall in 2018 - (Recall #: Z-0533-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

6.6F Plastic Dignity¿ Low Profile CT Port W/Attachable ChronoFlex¿ Polyurethane Catheter, Catalog # MRCTI66041, UDI#- 884908031157 Product Usage: 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: May 25, 2017

Date Posted: February 14, 2018

Recall Number: Z-0533-2018

Event ID: 78221

Reason for Recall:

The kit was packaged with the incorrect introducer needle size. The label indicates the kit contains an 18G Needle w/Echo Tip. The kits were packaged with a 21G Needle w/Echo Tip.

Status: Terminated

Product Quantity: 65 units

Code Information:

Lot # MHGB030 Exp. Date 2020-07-30

Distribution Pattern:

Arabia, Australia, Israel, Brunei & Jamaica

Voluntary or Mandated:

Voluntary: Firm initiated