FDA recall Z-2199-2025

MEDLINE INDUSTRIES, LP - Northfield · Class II · device

Product

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

Reason for recall

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.

Distribution

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

Key facts

Status
Ongoing
Initiation date
2025-06-16
Report date
2025-08-06
Voluntary/Mandated
Voluntary: Firm initiated
Location
Northfield, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2199-2025