Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc. recalls 4Fr x 20cm Single Lumen CT Midline Basic Tray, Product Code: VYML4S1001

Recall date

September 24, 2019

Source

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

Recall number

Z-0585-2020

FDA classification

Class II

Brand / firm

Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc.

Sold / distributed

One Customer Located in TN

Why it was recalled

Potential that 3Fr size catheter placed in the catheter tray instead of 4Fr for the 4Fr x 20cm Single Lumen CT Midline Basic Tray.

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

What was recalled

4Fr x 20cm Single Lumen CT Midline Basic Tray, Product Code: VYML4S1001