SwabFlush Prefilled Syringe with ICU Medical SwabCaps, 10mL Model no. EMZE010301
Pending LLM rewrite. Source: FDA_DEVICE Z-2199-2025.
Severity not yet assessed
We have not scored this recall against our rubric yet, so we are not showing a severity rating or our usual guidance. The agency’s own notice below is the authoritative source — read it first.
Plain-English summary
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.
The recalled product
- Product
- SwabFlush Prefilled Syringe with ICU Medical SwabCaps, 10mL Model no. EMZE010301
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Category
- Medical Device — Devices
Distribution
Distributed nationwide across the United States.
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