MEDLINE INDUSTRIES, LP - Northfield recalls SwabFlush Prefilled Syringe with ICU Medical SwabCaps, 10mL Model no. EMZE010301

Recall date

June 16, 2025

Source

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

Recall number

Z-2199-2025

FDA classification

Class II

Brand / firm

MEDLINE INDUSTRIES, LP - Northfield

Sold / distributed

Worldwide distribution - US Nationwide and the countries of Canada and Panama.

Why it was recalled

SwabFlush syringes are affected by the ICU Medical recall of their SwabCap Disinfecting Cap due to a manufacturing issue which affects the seal between the foil lid and plastic container of the Swab Cap. The issue may result in a reduced level of disinfection of the luer access valve, potentially resulting in patient infection/sepsis.

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

What was recalled

SwabFlush Prefilled Syringe with ICU Medical SwabCaps, 10mL Model no. EMZE010301