FDA-Device2025-08-06Class II
SwabFlush Prefilled Syringe with ICU Medical SwabCaps, 10mL Model no. EMZE010301
MEDLINE INDUSTRIES, LP - Northfield
Hazard
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.
Sold states
Worldwide distribution - US Nationwide and the countries of Canada and Panama.
Affected count
1,427,100 eaches
Manufactured in
3 Lakes Dr, Northfield, IL, United States
Products
SwabFlush Prefilled Syringe with ICU Medical SwabCaps, 10mL Model no. EMZE010301
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2199-2025Don't want to check this manually?
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