Vapotherm recalls Low Flow Disposable Patient Circuit for the Precision Flow System, Product Code PF-DPC-LOW

Recall date

December 16, 2022

Source

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

Recall number

Z-1272-2023

FDA classification

Class II

Brand / firm

Vapotherm

Sold / distributed

Worldwide distribution - US Nationwide and the country of UK.

Why it was recalled

There have been reports of excessive condensation associated with certain lots of the Low Flow Disposable Patient Circuits (DPCs) used with Precision Flow System which may lead to excessive rainout.

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

What was recalled

Low Flow Disposable Patient Circuit for the Precision Flow System, Product Code PF-DPC-LOW