Access Vascular, Inc recalls HydroPICC 5Fr Dual Lumen Maximal Barrier Kit, Product Model Number 80002004

Recall date

August 31, 2023

Source

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

Recall number

Z-0115-2024

FDA classification

Class II

Brand / firm

Access Vascular, Inc

Sold / distributed

US Nationwide distribution in the states of IL, TX.

Why it was recalled

Specific lots of the Dual Lumen HydroPICC Kits were provided with the incorrect revision of the Instructions For Use (IFU) which do not include the following warnings statement: HydroPICC Dual Lumen Catheter is for adult use only. There is a potential risk to health should the HydroPICC Dual Lumen Catheter be used in an inadequately sized vessel. There have been no reported adverse events to date.

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

What was recalled

HydroPICC 5Fr Dual Lumen Maximal Barrier Kit, Product Model Number 80002004