Class II

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

MEDLINE INDUSTRIES, LP - Northfield · June 16, 2025

Reason for Recall

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.

Distribution

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

States Affected

NATIONWIDE

Quantity Affected

1,427,100 eaches

Source: FDA (openFDA Device Enforcement)

Recall number: Z-2199-2025

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.