Recall
FDAHealthJune 16, 2025

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

⚠️ 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.

Is this relevant to me?

Geography
Nationwide
Source agency
FDA
Category
Health
Published
June 16, 2025

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

What's affected?

Product
SwabFlush Prefilled Syringe with ICU Medical SwabCaps, 10mL Model no. EMZE010301
Lot code
3144609

Additional details

UDI-DI 00363807103016 (ea) 10363807103013 (box) 20363807103010 (case) Lots 3144609 3144857 3144886 3144967 3145090 3145186

What should I do?

Recommended action

Class II recall. Voluntary: Firm initiated Quantity affected: 1,427,100 eaches.

View original FDA notice →

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