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Recall Observatory FDA recall evidence

Device product

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

Z-2199-2025

June 16, 2025

Class II

Product summary

Firm
MEDLINE INDUSTRIES, LP - Northfield
Event
Event 97169
Status
Ongoing
Classification
Class II
Quantity
1,427,100 eaches
Official record key
device-enforcement:Z-2199-2025

Official wording

Reason: 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.

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

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.