VasoNova, Inc. recalls VasoNova Vascular Positioning System (VPS ) G4 Console Catalog number VPS-G4C Cardiovascular: The VPS Stylet and Consol…

Recall date

March 30, 2015

Source

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

Recall number

Z-1408-2015

FDA classification

Class II

Brand / firm

VasoNova, Inc.

Sold / distributed

US Nationwide Distribution in the states of AZ, DC, PA, IN, PA. GA, NY, KS, CA, VA, NC.

Why it was recalled

A limited number of VPS G4 Consoles are being recalled due to noncompliance with International Electrotechnical Commission Standard 60101-1-1.

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

What was recalled

VasoNova Vascular Positioning System (VPS ) G4 Console Catalog number VPS-G4C Cardiovascular: The VPS Stylet and Console are indicated for guidance and tip positioning for central venous catheters.