Medical Components, Inc dba MedComp recalls SOFT-LINE DUO-FLOW DOUBLE LUMEN CATHETER TRAY; T3500 T4000 T4400 T4424

Recall date

July 12, 2018

Source

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

Recall number

Z-2939-2018

FDA classification

Class II

Brand / firm

Medical Components, Inc dba MedComp

Sold / distributed

Nationwide distribution; worldwide distribution.

Why it was recalled

The suture wings have the potential to crack or break. Potential patient injury includes catheter dislocation, bleeding, and air emboli. The firm has received six complaints (29 broken suture wings) to date for malfunction, without serious injury or death.

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

What was recalled

SOFT-LINE DUO-FLOW DOUBLE LUMEN CATHETER TRAY; T3500 T4000 T4400 T4424