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

Recall date

December 22, 2022

Source

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

Recall number

Z-1156-2023

FDA classification

Class II

Brand / firm

Access Vascular, Inc

Sold / distributed

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

Why it was recalled

Label with the incorrect component listed on the 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 Number: 80004004