—#214722

Product

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

FDA product code: QBP — Cap, Device Disinfectant
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K130975
Affected lot / code info: UDI-DI 00363807103016 (ea) 10363807103013 (box) 20363807103010 (case) Lots 3144609 3144857 3144886 3144967 3145090 3145186

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.

Root cause (FDA determination)

Process control

Action the firm took

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

Recalling firm

Firm: MEDLINE INDUSTRIES, LP Northfield
Address: 3 Lakes Dr, Northfield, Illinois 60093-2753

Distribution

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

Timeline

Recall initiated: 2025-06-16
Posted by FDA: 2025-07-30
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #214722. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.