Medical Components, Inc dba MedComp recalls 6.6F Plastic Dignity¿ Low Profile CT Port W/Attachable ChronoFlex¿ Polyurethane Catheter, Catalog # MRCTI66041, UDI#- 8…

Recall date

May 25, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0533-2018

FDA classification

Class II

Brand / firm

Medical Components, Inc dba MedComp

Sold / distributed

Arabia, Australia, Israel, Brunei & Jamaica

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.