Medical Components, Inc dba MedComp recalls 8F Plastic Dignity¿ Low Profile CT Port W/Pre-Attached ChronoFlex¿ Polyurethane Catheter

Recall date

November 22, 2017

Source

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

Recall number

Z-1271-2018

FDA classification

Class II

Brand / firm

Medical Components, Inc dba MedComp

Sold / distributed

CA, AR. AL

Why it was recalled

The kit was packaged with the incorrect guidewire. The label indicates the kit contains a marked guidewire. The kits were packaged with an unmarked guidewire.

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

What was recalled

8F Plastic Dignity¿ Low Profile CT Port W/Pre-Attached ChronoFlex¿ Polyurethane Catheter