MEDLINE INDUSTRIES, LP - Northfield recalls SwabFlush Prefilled Syringe with ICU Medical SwabCaps

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.

On June 16, 2025, the firm notified customers of the affected product. Customers were instructed to destroy the affected product for credit.

• FDA enforcement recordOfficial FDA database entry for Z-2199-2025
• FDA 510(k) clearance · K130975The device's official FDA premarket clearance record
• FDA device classification · QBPOfficial FDA classification for this device type
• CFR regulation · 21 CFR 880.5440The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find MEDLINE INDUSTRIES, LP - NorthfieldSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.