Access Vascular product recalled over labeling errors

Recall date

December 22, 2022

Source

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

Official notice title

Access Vascular, Inc recalls HydroMID 4Fr Single Lumen Maximal Barrier Kit- Indicated for short term access (<30days) to the peripheral venous acces…

Recall number

Z-1155-2023

FDA classification

Class II

Brand / firm

Access Vascular, Inc

Sold / distributed

US Nationwide distribution in the states of FL, TX, WA.

Why it was recalled

Product Mislabeled on the outer bag and inner kit Tyvek header bag

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

What was recalled

HydroMID 4Fr Single Lumen Maximal Barrier Kit- Indicated for short term access (<30days) to the peripheral venous access system for intravenous therapy Product Model Number: 80004004